Job Postings

Job Id —H001

Job Title —Validation Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

The Validation Engineer is responsible for using continuous improvement tools, such as FMEA, SolidWorks, Root Cause Analysis, SPC analysis,PPAP, APQP and process mapping.
Specifically, this includes:

- Designing and Perform GAP Analysis and Risk Assessments, Risk Management Plans, and design CAPA remediation strategies.

-Compile, analyze, and interpret preliminary experimental results using Microsoft Excel and a Minitab Statistical Software.

-ERP/MRP systems required related to Master data, BOM’s, production workflows and related topics.

Provided internal training for QMS functions including organizational training and subject matter expertise for QMS compliance, and process improvements, test method and process validations (TMVs) for new instrumentation, raw material properties and component qualifications. Maintained and used a variety of continuous improvement tools such as PPM reports, FMEA, and process mapping.
Specifically, this includes:

- Identify the Risk of the Software.

- Research for Software user Requirement’s.

- Develop/ execute all the required equipment qualification documentation for the Equipment Validation

- Product compliance with industry specifications, codes, and equipment standards.

Software planning documents and other process documents for the entire Software development lifecycle SDLC toward conformance with applicable regulations and standards ensuring software quality (21 CFR 820.30, IEC/ISO 62304, 13485, 14971,60601-1, FDA guidance documents) and Regulatory strategy for EU MDD and create necessary regulatory pathway and training and implementation tools per EU MDR Article 120 requirements.
Specifically, this includes:

- integration of complex suppliers, processes, materials, data and technology to meet manufacturing and delivery requirements.

- Setting-up design and development process as per 21 CFR 820.30 & ISO13485

Validation deliverables Validation Master Plan (VMP), Validation Summary Documents (VSD), Validation Summary Reports (VSR), Installation Qualification/ Operational Qualification/ Performance Qualification, and Requirements Traceability Matrix. Issues Log, Incident Reports, IQ Protocol/Report, OQ Protocol/Report and Trace Matrix Develop and execute verification tests for client systems (i.e. medical software)
Specifically, this includes:

- system inventory and assessment

-User requirement specifications

Executed informal and formal test procedures, gathered appropriate data and document results ,identified defects, provided input, created solutions and verification of defect resolution. Testing cycle on UAT, Integration, Migration, smoke and regression testing.
Specifically, this includes:

- Software Test methodologies (Black Box, White Box, Unit Testing, Software Integration, and HW/SW Integration testing)

Required Qualification & Experience:This role requires candidate to have at least a bachelor's Degree or Higher in Computer Information Systems, Computer Science or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H002

Job Title —Product Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

WORK BREAKDOWN STRUCTURE GOAL: Support the MTC manufacturing operations by continuous assessment of the indirect materials required to produce the final device, supplied by the supplier. Inspection and review of the materials to meet the required standard is the main goal of the work. The inspection process includes different testing, analyzing and resolve any issue related to the materials.

• This procedure is intended to capture material information throughout the life of the finished product.

• Finding every component detail, such as chemical information and structural formula, applicable material formulation information, specification of raw materials (including compounding ratios if relevant). manufacturer and supplier details.

• Will work on new process and template to release.

• Determining the surface area of the finished device to work with Microbiology team perform biocompatibility testing. Biocompatibility evaluation of components, materials and finished devices should be performed to all Medtronic finished product or component/material used in the manufacture of Medtronic products that have direct or indirect contact with the human body.

• Keep tracking of applicable vendor biocompatibility, chemical composition testing of raw materials.

• Collecting data regarding type of patient contact and duration of the contact for all catheters. This patient contact assessment will be done following ISO10993-1.

• Update material of concern table and consult with the R&D, Microbiology team members to determine if there are any regulatory implications of having any of these materials in the finished device.

• Will collaborate with Quality Management System (QMS) and Quality Documentation System to get approval of any supplier related issue.

• Will attend in classroom trainings and will complete online trainings to UpToDate with FDA regulations and standards and SOPs, Work instructions, Quality system regulatory requirements.

• As a part of Sourcing Continuity team I will be responsible for continuous improvement of supplier’s processes and materials.

• Maintaining continuity of supply of components purchased from different suppliers and qualification of supplier changes within the supplier and Danvers manufacturing sites. Initiate Change Order (CO) for all supplier change activities.

• Will work on Corrective and Preventive action (CAPA) associated with any type of supplier changes.

• Determination if the required material or service from the suppliers are within scope or out of scope following purchasing controlled documents. Make sure component qualification will be done to remain align with requirements, regulation

Required Qualification & Experience:Bachelors degree required in Engineering, Chemistry or closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H003

Job Title —Validation Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

- Development of design controls and DHF files, including FMEAs and research reports to remediate combination products that were filed as a drug and have no Design History File for the device constituent part.

- Develop Technical Studies, Risk Analysis, Process Mapping, DOE's, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.

- Responsible for Customer Complaint Investigations, Pre and Post market summary reports and Continuous Improvement projects, and Quality Systems Excellence among other projects.

- Work on revisions of uFMEA, DFMEA and pFMEA by effectively capturing user needs, design constraints, process inefficiencies and Hazard Analysis to ensure full proof safety.

- Assist in investigations associated with Out-of-Specification (OOS) and Non-conforming material reports (NCMR), Deviations, CAPA and Supplier Corrective Action Reports (SCARs).

- Author Project Initiation Document (PID), User Requirement Specifications (URS), and Product Requirement Specifications (PRS) documents.

- Apply quality engineering practices and guidance to support project team operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans.

- Develop and update the Trace Matrix to track requirements to ensure compliance with FDA regulations and quality review.

- Review and approve all the quality documents, quality procedures and Standard Operating Procedures (SOP’s).

- Independently provide comprehensive technical solutions for issues related to quality processes, procedures and systems to meet organizational and regulatory objectives.

- Utilize statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability.

- Work in collaboration with sister-sites and suppliers to get the information needed to author the required DHF documents.

Required Qualification & Experience:at least a Bachelors degree or higher in an engineering discipline such as industrial Engineering, Mechanical engineering, Manufacturing Engineering, or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H004

Job Title —Cleaning Valiadtion Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Validate manufacturing processes, Develop Equipment Cleaning methodology within acceptance criteria.

• Developed Equipment Critical cleaning parameter as per Notebook study Performance.

• Adapt machine or equipment design to production condition. May incorporate inspection and test requirement into the manufacturing plan.

• Generated Detail Design Specification for the entire process.

• Inspect Cleaning performance over equipment, tools, and manufacturing parts to verify efficiency, and investigates and initiates corrective action of problem and deficiencies to ensure product quality.

• Develops manufacturing processes that are applicable to statistical process control and may develop those technique Ensure process and procedures are in compliance with regulation.

• Responsible for maintaining interdepartmental relationship by coordinating with Operation, Quality, Manufacturing, Validation and Engineering (quality control) department about the scheduling of protocol execution, submission of samples for testing and final report approval.

• Investigated manufacturing challenges and evaluated/implemented process improvement.

• Supported manufacturing facility through the validation of cleaning processes for new manufacturing equipment.

• Involved in selection and determination of Cleaning agents, Surface Area calculations and Acceptance Criteria limits.

• Develop equipment load patterns for equipment washers to clean parts effectively.

• Manage and Coordinate the Validation Master Plan and associated schedule and all related documentation.

Required Qualification & Experience:

• Bachelor's Degree: Mechanical Engineering or Bio Medical Engineering or a closely related field. Master's degree a plus. Individual needs to communicate effectively with people in Engineering, Manufacturing, Research and Development, and vendors. Solid technical foundation is critical to success.

• Knowledge of applicable regulatory standards, cGMP and GDP Guidelines.

• Application of knowledge in multiple disciplines, such as Biochemistry, Bio Medical, mechanical engineering etc.

• Documentation skills must be such that logic to the conclusions is easily followed.

• Ability to apply appropriate statistical methods to better understand and improve plant equipment and processes, evaluate new or changed equipment or processes and resolve quality problems.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H005

Job Title —Packaging Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:Device and packaging configuration assessments to determine the worst-case devices to be tested in packaging and sterilization studies. Device and packaging configuration assessments to identify opportunities to streamline end-level packaging configuration changes. Write, prepare, and execute packaging testing protocols to conduct seal characterization studies to determine the effects of revised sterilization process and suppliers. Analyze data and prepare subsequent reports Write, prepare, and execute packaging testing protocols to conduct packaging design verification and distribution testing. Analyze data and prepare subsequent reports Coordinate sample sealing with process engineers and operations management in ISO class 7 and 8 cleanrooms. Organize all training of test protocols, sample submission, and testing with internal and external labs. Ensure activities are compliant with FDA design controls, processes and regulations. Create and/or update packaging design history files (DHF) to include current test report references, updated risk assessment documentation, and other design and quality assessments Prepare and implement packaging bills of materials (BOM) changes, and manufacturing procedure changes as needed Plan and/or attend regularly scheduled meetings (in-person and virtual) to ensure project timelines are maintained and that milestones are achieved. Attending daily review meetings and stand-ups with other departments for the latest updates. Confirm all required company-assigned training is completed on-time.

Required Qualification & Experience:This role requires candidate to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical engineering, electrical engineering, manufacturing engineering or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H006

Job Title —Validation Enngineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Shape Metal Alloy and Nickel-Plating expertise to determine that Mixed Flow Gas is the proper test method to use to determine the impact of Nickel-Plating Stability.

• OmniPod Product Expertise to evaluate how the Nickel-Plating Stability impacted primary functionality of the OmniPod as measured by Pulse Width.

• Probability and Statistics expertise to determine appropriate sample sizes for the testing.

• "Soft-Skills" to manage and meet the expectations of Vice President level management with $12,600,000 worth of impacted product.

• Gage Repeatability, Reproducibility and Reliability to assess the precision and bias of the proposed test method and the applicable gage.

• Metrology and Surface Engineering as well as Engineering Drawing to perform a Root-Sum Squared Method stack up analysis to determine and appropriate specification.

• Engineering Drawing, OmniPod Product Expertise, and Force Testing expertise to evaluate the possibility of a Commutator Cap Nipple Crush Condition (a potentially severe defect if present in an OmniPod.

• Advanced Problem Solving and Systematic Root Cause Analysis to lead a cross functional team in the identification of potential root causes and the development of corrective actions to permanently resolve the contamination issue.

• OmniPod Product expertise to build worst case challenge samples representative of the types of defects seen in normal production conditions. The Beneficiary then partnered with lnsulet Corporation's internal chemistry team to determine appropriate testing to determine if the contamination could cause a health impact to users of the Omni Pod.

• OmniPod Manufacturing Process expertise to determine potential sources of contamination present in the process and drive long term improvement to the process.

Required Qualification & Experience:At least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, engineering management, manufacturing engineering, or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H007

Job Title —Validation Enngineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.

• Working on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.

• Quality engineering reviews and development of Work instructions, Inspection procedures, Test Method Validation & Verification, Supplier controls, IQ, OQ, PQ, Product label reviews and User requirements.

• Working on systems like Trackwise, CRMS (Corporate Records Management System), Maximo EAM, Share point and Electronic Quality Management System (EQMS).

• Actively involving in writing, reviewing and approving various Analytical Methods for drug substance and drug products, Method Validation Protocol, Process Validation Protocol, Cleaning Method Validation Protocol, Stability Protocols, Method Transfer Protocols, various analytical method tests Reports, new and revised SOPs, and chemistry laboratories documents.

• Involving in creating Validation strategy and Validation master plan to establish a process for fulfilling the validation activities.

• Responsible for Execution of test scripts and reporting using HP ALM in QA/UAT & Production Environment for Trackwise & Labware LIMS

• Actively involving in Quality Management Support Activities (QMS), Control Plans, Qualifications, Process Validations, gage R&R's along with Design Verifications and Design Reviews, and implementation of new test methods.

• Involving in accessing Maximo EAM tool for Equipment assets creation, Workorder Management, Preventive Maintenance Plans, Calibrations functionality.

• Involving in execution of implementation plans for Preventive maintenance of equipment’s and processing service requests in Maximo EAM.

Required Qualification & Experience:At least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical Engineering, Manufacturing Engineering or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H008

Job Title —Quality Enngineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Required Qualification & Experience:Bachelors degree or higher in engineering such as industrial engineering , mechanical engineering, engineering management, manufacturing engineering or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H009

Job Title —Cleaning Validation ( Manufacturing Technology), at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Validate manufacturing processes, development equipment cleaning methodology within acceptance criteria.

• Develop equipment critical cleaning parameter as per notebook study performance.

• Adapt machine or equipment design to production condition. May incorporate inspection and test requirement into the manufacturing plan.

• Generated detail design specification for the entire process.

• Design Specification identify input and output of manufacturing process.

• Developing Process Design Specification for Vaccine Manufacturing industries helpful overcome output product failure.

• Developing design process for Vaccine flow Pipe Line and specified Pipe design calculation for meet manufacturing process criteria.

• Inspect cleaning performance over equipment, tools, and manufacturing parts to verify efficiency, and investigates and initiates corrective action of problem and deficiencies to ensure product quality

• Develop manufacturing processes that are applicable to statistical process control and may develop those technique ensure process and procedures are in compliance with regulation.

• Responsible for maintaining interdepartmental relationship by coordinating with operation, quality, manufacturing, validation and engineering (quality control) department about the scheduling of protocol execution, submission of samples for testing and final report approval.

• Investigate manufacturing challenges and evaluated/implemented process improvement.

• Support manufacturing facility through the validation of cleaning processes for new manufacturing equipment.

• Involved in selection and determination of cleaning agents, surface area calculations and acceptance criteria limits.

• Develop equipment load patterns for equipment washers to clean parts effectively

• Manage and coordinate the validation master plan and associated schedule and all

Required Qualification & Experience:Require candidate to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, manufacturing engineering, or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H0010

Job Title —Engineering Tech Support, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Responsible for performing process, equipment, and software validation activities including, executing, analyzing statistical data for process and equipment validation.

• Analyzing data using statistical principles and software’s like Minitab, solid work. Writing validation protocols and reports, GDP review of data and reports, and validation protocols, reports, and deviations.

• Responsible for working in a team to perform validation activities of different pouch sealing machine like Multi-vac, AccuSeal and tray sealing machines like Alloyed Aergo Plus tray sealer and Atlas-Vac tray sealer.

• Write Test Method Validation Protocols, report of Bubble Emission Test for Tyvek Trays for different customers and execute as per ISO 13485, ISO 11607 and cGMP standards.

• Write protocols and Perform Design of Experiment (DOE) for different validation projects like pouch sealer and tray sealer equipment.

• Work on different gaps found in validations history and mitigate with proper rationale as per the FDA standards.

• Create and perform sample plan, test plan and control plan for the validation protocol and execute with proper planning and analyze the result with different statistical software’s.

• Perform and Analyze Gare R&R study, process capability (Cpk and Ppk), seal strength testing (peel test), control charts using software like Minitab.

• Create job order picklist, engineering run as per required and prepare the sample in the floor or in the clean room class 7.

• Thoroughly understand the standard operating procedure, work instructions, preventive maintenance plan, suggest if any edits are necessary and implement during the validations.

• Perform different test method like Visual Inspection, Dye Penetration (F1929), Bubble Emission Testing, Seal strength Testing for various sterile barrier system (SBS).

• Create project timeline, risk analysis and assessment, sampling, and control plans, FMEA, Time-Study for the given validation project.

• Proper knowledge and experience in regulatory requirements including ISO13485, ISO14971, ISO9001, quality systems regulations (21 CFR: 820).

• Other duties as assigned.

Required Qualification & Experience:Requires at least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, manufacturing engineering or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H0011

Job Title —Quality Assurance Analyst, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:Responsibilities may include the following and other duties may be assigned. Consults with business stakeholders to understand and evaluate current business processes and identify complex business problems and needs turning those needs into system requirements. Provides technical expertise for system functional specifications and deploys new and current systems, processes and procedures in a cost-effective manner. May configure system settings and options; plan and execute unit, system, and integration testing to meet business requirements. May lead cross functional linked teams to address business or systems issues.

SPECIALIST CAREER STREAM: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS: Autonomy - Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects / processes.

ORGANIZATION IMPACT: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

INNOVATION & COMPLEXITY: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.

COMMUNICATION & INFLUENCE:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making. LEADERSHIP & TALENT MANAGEMENT: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Required Qualification & Experience:At least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, manufacturing engineering, or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Id —H0012

Job Title —Quality Assurance Analyst, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

Expectations for this position include working knowledge of local and some of the global, regulations as they pertain to quality areas with primary emphasis on clinical processes. This position requires the ability to support the Medtronic IT Clinical area systems validations, maintenances, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk, qualify their severity and address gaps in a methodical way to reduce overall organization exposure. Communication, collaboration, and organization skills are crucial for the fulfillment of this position. Attention to detail and timely completion of planned activities are necessary for the success of the candidate in this role.

POSITION RESPONSIBILITIES:Overall responsibilities of this Quality Analyst position include: • Providing the necessary support to enable the Clinical IT Tearn to make changes or implement new systems in compliance with our IT quality processes and with applicable regulations and standards

• Enforcing full adherence to our quality management system policies, processes, and procedures

• Improves first pass yield quality by analyzing the documentation submitted for review and working with customers to improve critical areas

• Provide first local response to the support of the Clinical IT Area. • Track and report quality deliverables review metrics per OLA/SLA

• Contribute to training on IT processes to support project documentation authors in effort to improve overall quality of documentation QA is reviewing/approving

• Understands and remains knowledgeable on all applicable policies and procedures pertaining to the specific functional area being supported. This includes those within the Global IT Quality Management System (QMS) but may also include other policies and procedures within the Corporate Quality Management System. This helps to ensure our compliance to regulatory requirements and applicable standards.

BASIC QUALIFICATIONS: EDUCATION: • Bachelor's Degree

EXPERIENCE:• 4+ years quality assurance / information technology experience with Bachelors or 2+ with Masters

SPECIALIZED KNOWLEDGE REQUIRED:

• Experience leading Quality and I or audit efforts in a regulated environment

• 5+ years in working with quality, manufacturing or clinical business processes

DESIRED/PREFERRED QUALIFICATIONS:

• Solid understanding of the quality regulations and auditing techniques required for the medical device industry

• Demonstrated analytical thinking, process mapping, process improvement and problem solving skills

• Ability to create and deliver presentations up to the Director level in the organization

• Excellent communication skills (oral, business writing, presentations and listening) • Strong influencing and negotiation skills

• High energy and motivation with an ability to adapt to change

• Ability to apply advanced in-depth knowledge of quality assurance practices across Quality, Manufacturing Execution or Clinical IT Systems

• Provides solutions to a wide range of difficult problems using multiple root cause analysis techniques (e.g., 5 whys, fishbone diagram, etc.)

• Analyzes complex issues and significantly improves, changes, or adapts existing methods

• Works independently or collaboratively to determine and develop approaches to solutions with very little to no supervision or direction.

• Exerts significant influence in the organization to help establish and meet quality objectives and long range goals.

• Determines and pursues courses of action necessary to obtain desired results

• Expected to provide guidance about quality related work activities

• Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs. As functional subject matter expert on quality, may lead sessions with internal auditors and may be in front of an external regulatory agency.

• Facilitate timely issue resolution and escalation, as appropriate

• Ability to manage multiple, complex priorities • Developed interactive skills (e.g., instruction, presentation, conduct training, interviewing, and meetings) and interact effectively with all levels of management

• Certifications with CobiT, ITIL, PMP helpful.

Required Qualification & Experience:At least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering,electrical engineering, manufacturing engineering or a closely related field

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Mechanical Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Coordinate project recommendations and work with our full-service team of Architects, Engineers.

• Serve as Project Engineer for work involving Mechanical (HVAC controls) and Plumbing systems.

• Apply skills to prepare and direct construction documentation, studies, and other critical reports.

• Developing project documents such as calculations, reports and construction drawings and specifications, for clients, according to regulatory and industry standards.

• Perform energy calculations using Energy Pro software to ensure the buildings comply with Title 24 code.

• Prepare energy analysis reports based on Title 24 energy calculations.

• Coordinating with other disciplines and other internal and external team members (e.g. vendors, clients, and contractors).

• Assisting with design development and coordinating with the design team at the direction of the Lead Mechanical Engineer.

• Developing Mechanical / Utility equipment and construction specifications.

• Developing temperature / humidity control calculations, airflow diagrams, pressurization plans, and classification plans.

• Using Revit for sizing and developing layouts for ductwork and piping plans and meeting with architects to authenticate and finalize the designs.

Required Knowledge and Experience:Bachelors Required or Masters’ degree (preferred) in Mechanical Engineering from an accredited university

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Validation Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Collecting product specific requirements provided by the product manager using TestTrack client© ensuring all the requirements are recorded before testing.

• Co-ordinate with the development team to identify and capture test cases, creating test cases in TestTrack client© covering all the scenarios which the user might encounter while using product developed based upon requirements.

• Executing and running all the test cases created in TestTrack client in different environments before going into production to ensure that the product works as specified.

• Report issues through a formal bug tracking system as well as work with the development team to help isolate debug resolve issues/bugs so they don’t end up in production.

• Responsible for creating validation plans that adheres to BioTel and Quality guidelines as per FDA requirements.

• Create all the Quality Approval documentation i.e. Functional Requirements Specifications, System Release Document, Verification and Validation test plans, 21 CFR Part 11 checklist required for the Quality Approval before the release of product.

• Ensuring regulatory compliance in validation process with FDA 21 CFR part 11, QSR and ISO 13485 regulatory requirements.

• Understanding the design and Implementation of the functional components of a new or revised product, program and process.

• Determining risk analysis to identify the potential risk and its severity prioritizing them to test to avert the possible vulnerability to the system.

• Ensuring regulatory compliance in validation processes with FDA 21 CFR Part 11, QSR and ISO 13485 regulatory requirements

• Ensuring the team has well understood “definition of done” for sprint backlog, Partnering with Scrum Master to drive continuous improvement within the Agile team

Required Knowledge and Experience:Minimum Requirement of a Bachelors Degreeor higher in an Engineering

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Validation Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Development of design controls and DHF files, including FMEAs and research reports to remediate combination products that were filed as a drug and have no Design History File for the device constituent part.

• Develop Technical Studies, Risk Analysis, Process Mapping, DOE's, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.

• Responsible for Customer Complaint Investigations, Pre and Post market summary reports and Continuous Improvement projects, and Quality Systems Excellence among other projects.

• Work on revisions of uFMEA, DFMEA and pFMEA by effectively capturing user needs, design constraints, process inefficiencies and Hazard Analysis to ensure full proof safety

• Assist in investigations associated with Out-of-Specification (OOS) and Non-conforming material reports (NCMR), Deviations, CAPA and Supplier Corrective Action Reports (SCARs).

• Author Project Initiation Document (PID), User Requirement Specifications (URS), and Product Requirement Specifications (PRS) documents.

• Apply quality engineering practices and guidance to support project team operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans.

• Develop and update the Trace Matrix to track requirements to ensure compliance with FDA regulations and quality review.

• Review and approve all the quality documents, quality procedures and Standard Operating Procedures (SOP’s).

• Independently provide comprehensive technical solutions for issues related to quality processes, procedures and systems to meet organizational and regulatory objectives.

• Utilize statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability.

• Work in collaboration with sister-sites and suppliers to get the information needed to author the required DHF documents.

Required Knowledge and Experience:Minimum Requirement of a Bachelors Degreeor higher in an Engineering Discipline such as Industrial Engineering, Mechanical Engineering, electrical engineering, Manufacturing Engineering or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Business Analyst, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Participate in development and review of all of the artifacts such as Business Requirement document, functional specifications, and QA test plan.

• Elicit business requirements, and interpret them into practical technical solutions

• Interact and coordinate with system developers and business subject matter experts on application changes, development, and deployment

• Create and maintain system and user documentation

• Provide regular verbal and written reports to management and business community

• Participate in systems and processes design and implementation efforts.

• Perform other related duties as required and assigned

• Demonstrate behaviors which are aligned with the organization’s desired culture and values

• Must have experience in developing Enterprise level applications using different technology

• Ability to interpret XML

• Ability to work on multiple Projects

• Understanding of Secondary Pricing across investor products/guidelines

• Excellent interpersonal and verbal/written communication skills a must

• Excellent organizational and analytical skills a must

• Correspondent/retail origination Experience

• Must be highly proficient in Excel and Word

• Must be a team player with strong attention to detail and able to work independently

• Proven track record at delivering timely and accurate information in a fast-paced environment

• Excellent critical thinking, problem solving, mathematical skills and sound judgment

• Financial Services and, if possible, mortgage industry experience preferred

• Strong business acumen and ability to interface with executive management

Required Knowledge and Experience:Minimum Bachelors degree or Higher in Computer science, a relevant technical engineering discipline

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Validation Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

SPECIALIST CAREER STREAM:Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS AUTONOMY:Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

ORGANIZATIONAL IMPACT:May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

INNOVATION AND COMPLEXITY:Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.

COMMUNICATION AND INFLUENCE:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision making.

LEADERSHIP AND TALENT MANAGEMENT: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience:Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

Minimum Requirement of a Bachelors Degreeor higher in an Engineering Discipline such as Industrial Engineering, Mechanical Engineering, electrical engineering, Manufacturing Engineering or a closely related field.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Quality Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

1- Experience in process validation (Installation Qualifications, Operational Qualification and Process Qualifications)

2- Experience with Test Method Validation, Gage R&R

3- Experience with Minitab for statistical analysis

4- Experience with DMAIC and DRM tools

5- Experience with Production Manufacturing, cGMP and FDA CFR 820 Regulations

6- Experience with Class I, II and III Medical device manufacturing

7- Experience with production controls, fixture design and qualifications,

8- Experience with transfer activities such as product line transfers from one site to another

9- Experience with Internal supplier quality controls such as completing Intra quality agreement etc…

10-Experience with addressing non-conformances and basic root cause analysis.

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM:Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS AUTONOMY:Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

ORGANIZATIONAL IMPACT: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

COMMUNICATION AND INFLUENCE:Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Sr.Manufacturing Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. May be involved in process validation activities (IQ/OQ/PQ).

SPECIALIST CAREER STREAM:Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS AUTONOMY:Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.

COMMUNICATION AND INFLUENCE:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Design control Quality Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Write/Review and maintain technical documents such as test protocols, test reports, SOP’s, design verification/validation, engineering specifications, and related information to obtain knowledge of methods, procedures, and activities.

• Provide design control engineering tactical expertise to develop TAR-200 and Inserter.

• Define document requirements for products, process, and test methods verifications and validations per FDA QSR’s and specific Design Control projects activities.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

• Review and approval of Design Control elements, including but not limited to Planning, Device History File(s), Change Control, and associated and supporting documentation.

• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.

• Evaluation of component and system-level specifications relative to customer needs and product performance specifications.

• Ensure technical integrity of the design control process is met, including content compliance and completeness of the design history file (DHF), collaboratively communicating and resolving gaps, and supporting the transition of the design project into sustaining engineering.

• Apply problem-solving and quality improvement tools and techniques, including preventative and corrective actions, and how to overcome barriers to quality improvements.

• Acquire and analyze data using appropriate standard quantitative methods to facilitate process analysis and improvements.

TECHNICAL SPECIALIST CAREER STREAM:An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues. Most of the time is spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS:

Autonomy:Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/ assignments.

Organizational Impact:Sets objectives for own job area to meet the goals of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional tasks.

Innovation and Complexity:Problems and issues faced are general and may require an understanding of a broader set of issues or other job areas but typically are not complicated. Adjusts or recommends enhancements in systems and processes to solve problems or improve the job area's effectiveness.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.

Leadership and Talent Management:May provide guidance and assistance to entry-level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.

The minimum requirement for performance of these duties is a bachelor’s degree in Mechanical engineering or a closely related field.

EOE. Apply to Fax # 866-849-7714.

Job Title —Manufacturing Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Lead Engineer to support the change management and co-ordination work.

• Create project implementation/high level completion plan by coordination with Quality, Planning, Manufacturing & Packaging teams.

• Work on Product change management process and coordinate with multiple departments.

• Responsible to direct, oversee and update a variety manufacturing processes and documents e.g. Failure Mode Effect Analysis (PFMEA, DFMEA), Route Sheets, create or update technical files such as Process Specification, Material Specification, Control Plans, Test Reports, AQR (Automated Quality Records), Use Ss, 5 Why, Root cause analysis, Kanban etc.

• Perform time studies to reduce cycle time, process costs and improve productivity of the manufacturing packaging line.

• Create or update Critical Control Plan (CCP), Risk Management Report (RMR), Validation Master Plan (VMP), Training Reports (TRs) for the packaging line as per change in processes.

• Write Protocols & Reports of IQ(lnstallation Qualification), OQ (Operation Qualification), PQ (Performance Qualification).

• Update BOM (Bill of Materials) and Vision systems as per the process change.

• Understand all engineering drawings to figure out accurate artwork numbers, part numbers and packaging assembly details.

• Setup the tolerances to each packaging weight scales to accept/reject inspection samples.

• Work on GR&R/TMV (Test Method Validation) for each packaging line.

• Create protocols & completion reports for Test Method Validations.

• Create ECN’s (Engineering Change Notice) to record design, process changes throughout lifecycle phases of a product/processes.

• Collaborate with cross-functional teams including Quality, Labeling, Packaging, Regulatory, Project leadership.

• Daily, Weekly meeting with Project Leads, Plant Manager & relevant teams for status updates, collecUprovide data.

EOE. Apply to Fax # 866-849-7714.

Responsibilities:

• Support the Validation Supervisor to ensure effective Validations execution and maintenance of manufacturing equipment, facilities and process utilities.
• Track and Report action plan status/completion as relates to Validation Systems improvement efforts.
• Responsible for Developing and Executing Qualifications, Validations, Re-Qualifications and Re-Validations for Process Equipment, Laboratory Equipment, Utilities and Facilities.
• Generate and Execute Validation Project Plans, Validation protocols (IQ/OQ/PQ), Summary Reports and SOPs as required by Validation Master Plan, SOPs and Global Policies. Systems include Incubators, BSC’s, Autoclaves, Bioreactors, Process Gases, DI Water System, Laboratory Freezers, classified Clean Rooms/HVAC(Grades A through D).
• Work Independently (Author Protocol, Execute Studies, Analyze Data and Author Reports).
• Discuss Expectations for Validation Activities, Program and Documentation.
• Handle some midsize project work but with oversight at a moderate degree.
• Plan and Organize qualification, validation and verification activities amongst cross functional groups.
• Provide and Maintain status updates for validation activities related to day to day operations or project work.
• Assess Change Controls with an accurate understanding of the bigger picture implications of changes, review, oversight and feedback.
• Generate summary and detailed reports to recapitulate the validation results.
• Responsible for Validation life cycle, Validation protocols (IQ/OQ/PQ) generation and execution of manufacturing equipment, laboratory equipment, clean process utilities and classified facilities.
• Work with validated computer systems and change management in the pharmaceutical/ biotech industry, including training others.
• Ensure GMP compliance, 21 CFR parts 210, 211, 11, GAMP 5 and ISO 13485: 2003 requirements.
• Handle Kaye Validator and Ellab Data Acquisition Systems including SIM setup, Pre- and Post-calibration of Thermocouples.
• Perform temperature mapping studies using Kaye validator and Kaye data loggers for Manufacturing & Sterile Supply support equipment.
• Perform temperature mapping studies using Ellab Data Acquisition System and Ellab Data Loggers for Manufacturing & Sterile Supply support equipment.
• Analyze and Interpret validation test data to determine whether systems or processes have met validation criteria or to identify root causes of deviations.
• Generate Deviation reports, Perform root cause investigation and Document Corrective & preventive action (CAPA).
• Perform Statistical analysis of data and use of on site softwares - Data Management System (DMS), Spreadsheets, Validations Tracker spreadsheet, Fieldglass, Word processing software, SAP, and Trackwise systems.
• Use Kaye Validator Software and Valsuite Validation & Calibration Software - ELLAB.
• Use experience and knowledge to solve problems. Seek direction from the department head and make some recommendations for the department.
• Identify and Respond to day to day problems, interpret data and draw valid conclusions.
• Improve efficiency of Self and Team by defining, analyzing problems and implementing new ways of approaching work.
• Manage Day to day tasks, mid size projects, establish department goals, prioritize own work and organizational skills.
• Write procedures and reports; communicate status, needs and timelines effectively to management; use people skills to resolve or avoid conflict.

Minimum Requirements:Bachelor's degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, engineering management, manufacturing engineering, or a closely related field.

Job Title —Quality Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Bachelor’s degree in Engineering or other technical discipline and a minimum of 2 years of related experience.

• Master’s degree in engineering or Technical discipline and 0-2 years of related experience

Preferred Education and Experience:

• Medical Device industry experience preferred along with ASQ-CQE Certification.

• Formal Project Management training

• Minitab, Statistical Process Control software application experience

• Experience in a High-Tech manufacturing environment providing direct process support

• 5 years direct Quality experience

• Designs gages and fixtures to improve and simplify inspection of products. Conducts gage design reviews with Tooling Team personnel and interfaces with Sourcing personnel, suppliers, and outside gauging suppliers as needed.

Performs Quality Planning Design reviews for new products and launches which may include preparation of:

• PFMEAs

• Control Plans

• Criteria development

• Critical to Quality characteristic identification.

• Depositions nonconforming product. Processes associated nonconformance reports (MCDRs), deviation requests (ERBs) and CAPA requests (CARs) accordingly.

• Develops IQS criteria and insures that features are properly identified and in agreement with engineering drawings. Approves and initiates associated change requests as required (Memo to File, Engineering Change Order).

• Optimizes inspection criteria to improve quality throughout manufacturing and at final inspection while insuring product functionality.

• Reviews QC work histories to identify products requiring high inspection times and rejections and reviews so changes to processes or specifications can be identified and improvements made to increase quality and throughput.

• Trains Medtronic employees and supplier personnel in specific product requirements and Quality tools and techniques.

• Tracks and Trends Quality Data; reviews QC work history to optimize inspection throughput. Generates CAPA requests as required to address systemic problems ascertained via data analysis.

• Develops SPC and associated data collection methods.

• Recommends and implements improved gauging methods for in-process and final inspection operations.

• Responsible for maintaining standardizing and optimizing product inspection procedures.

• Specifies and requisitions measuring and gaging equipment as required.

• Makes appropriate changes in Gauging and inspection procedures when dictated by engineering drawing changes. Documents all changes through the appropriate control system.

• Resolves technical production problems on assigned product lines involving gauging and inspection procedures working with shop employees and suppliers and other team personnel.

• Performs technical quality reviews of suppliers to support purchasing personnel certifying suppliers.

• Makes recommendations for upgrades, acquisitions and enhancements related to equipment and software to support and improve the quality system.

• Travels as required for company business which could be extensive at times. May include visits to supplier facilities, visits to Memphis for meetings, visits to other Medtronic facilities, and travel to training classes or seminars.

• Performs supplier audits and source inspection activities as required.

• Supports supplier approval process as required.

• Utilize PFMEA tools to perform process improvements

EOE. Apply to Fax # 866-849-7714.

Job Title —Test Engineer II, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Collecting product specific requirements provided by the product manager using TestTrack client© ensuring all the requirements are recorded before testing

• Co-ordinate with development team to identify and capture test cases, creating Test cases in TestTrack client© covering all the scenarios which the user might encounter while using product developed based upon requirements

• Executing and running all the test cases created in TestTrack client© in different environments before going into production to ensure that the product works as specified

• Report issues through a formal bug tracking system as well as work with the development team to help isolate debug resolve issues/bugs so they don't end up in production

• Responsible for creating Validation plans that adheres to BioTel and Quality guidelines as per FDA requirement

• Collecting objective evidence meeting all the acceptance criteria documented in the validation Plan

• Responsible for partnering with Scrum master to analyze and continuously improve validation process within the Agile team

• Create all the Quality Approval documentation i.e. Functional Requirement Specification, System Release Document, Verification and Validation test plans, 21 CFR Part 11 checklist required for the Quality Approval before the release of product

• Ensuring regulatory compliance in validation process with FDA 21 CFR part 11, QSR and ISO 13485 regulatory requirements

• Understanding the design and Implementation of the functional components of a new or revised product, program and process

• Determining risk analysis to identify the potential risk and its severity prioritizing them to test to avert the possible vulnerability to the system

• Ensuring the team has a well understood "definition of done" for sprint backlog and development and maintenance of regression test suites

Required Qulification:Bachelors in Engineering

EOE. Apply to Fax # 866-849-7714.

Job Title —Manufacturing engineering, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Medical Device/Pharma manufacturing engineering experience (1 to any number of years’ experience)

• Experience writing/executing validations

• Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.

• Engineering change/documentation experience (any) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Communication and Influence:Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision making.

Leadership and Talent Management:May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience:Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

EOE. Apply to Fax # 866-849-7714.

Job Title —Director of Engineering, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

(VAStek, Inc. has opening in San Diego, CA) Direct initial program planning including proposal philosophy coordination, technical baseline definition, proposal preparation; subcontractor statements of work specifications; estimation of product or service costs. Establish procedures and assignments to be followed to meet program completion dates as planned; ensure that estimates of manpower needs, costs and budgets are prepared, established and monitored. Review and evaluate progress of subordinate activities including: review job performance of subordinates and personnel assigned to program, ensure assignments are given according to individual capabilities and promotions, transfers, terminations, compensation change are acted upon where warranted. Act as spokesman to customer personnel on engineering capabilities. Support creation of Vastek company proposals by obtaining detailed project information and requirements, structuring and organizing undefined tasks, and creating project plans and estimates. Provide technical leadership in customer meetings as a subject matter expert on system design, test and manufacturing best practices. Manage selection, training, development and performance management for Vastek technical team. Manage the day-to-day business activities of the team to achieve key business objectives and strategies, with an emphasis on growth. Manage geographically dispersed, multi-disciplinary technical teams. Position requires up to 25% domestic and up to 10% international travel.

Requires Bachelor of Engineering (any field) and 5 years progressive experience OR Masters of Engineering (any field) and 2 years experience. 2 years of experience must include:

• Working in a regulated product development environment such as medical devices or pharmaceuticals

• industry standards for commissioning, qualification, and operation of facilities and utilities for cGMP manufacturing

• working with teams in multiple geographical locations including Southeast Asia

• managing cross-functional teams and collaborating across the business

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).

Job Title —Cleaning Validation Specialist, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Perform protocol execution of CIP and COP cleaning validation, product process and cleaning continuous verifications

• Perform continuous verifications of validated processes and cleaning equipment

• Responsible for drafting process and cleaning validation study protocols

• Perform GAP analysis of previous executed protocols

• Cleaning Validation Strategy using worst-case cleaning approach, risk-based product grouping approach

• Review/modify the product-equipment based Cleaning Validation Matrix for entire site based on cleaning-ability, toxicity, potency and solubility

• Provide support to the manufacturing, engineering and quality assurance for cleaning and cleaning validation activities

• Responsible for generating equipment characterization reports, FMEA studies

Requires Bachelor of Engineering

EOE. Apply to Fax # 866-849-7714.

Job Title —Manufacturing Engineering Specialist, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

(VAStek, Inc. has opening in San Diego, CA)Analyze the market demand for different contracting manufacturing engineering personnel. Use analysis of metrics and knowledge of manufacturing engineering principles to determine the suitability and feasibility of specific employees for specific client requirements as well as the suitability of specific projects for fulfillment by company. Will work in unanticipated locations.

Minimum Requirment: Requires Masters in Industrial Engineering, Manufacturing Engineering, or Industrial Technology

Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101 (refer to job title).

• Responsible for developing and executing the validation plans according to the approved procedures, collation of test results, organize data packages and maintain all documentation pertaining to validation.
• Comply and analyze validation data, prepare reports, and route documentation.
• Manage Change Control Management System (CCMS).
• Investigate and troubleshoot problems that occur during the development and deployment phase and determine the solutions.
• Perform Periodic reviews and data integrity and security assessments as needed.
• Coordinate and execute validation change control and preparation of draft protocols, reports, and data tables.
• Participate in cross-functional project teams with the support of quality and other groups.
• Contribute directly to the completion of projects through the management of assigned contract personnel, development, and execution of validation change control documents, and development and review of protocols, reports, and data tables generated by peers and contract personnel.
• Independently apply validation principles to work assignments, review and approve documents and resolve problems.
• Utilize standalone computerized instruments and software such as HPLC, UPLC, etc.

THIS POSITION DOES NOT SUPERVISE ANY OTHER PERSONNEL.

Minimum Requirements:Bachelor’s degree or higher in Business Administration, Information Systems, Management Information Systems, Computer Science, or any related IT field of study, plus at least one (1) year of experience in the job offered or in any related position(s) involving evaluation, validation and/or testing of systems.

No travel; no telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each long-term project.

Additional Information:

• Job Site: 1230 Columbia Street, Suite 1180. San Diego, CA 92101.
• Travel Details (if applicable):No travel; no telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each long-term project.
• Mail Resumes To: Bianca Garcia, HR. 1230 Columbia Street, Suite 1180. San Diego, CA 92101.
• No calls or emails. EOE.

Must be legally authorized to work in the United States without sponsorship

Job Title —Supplier Quality Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Specialist Career Stream:Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors Autonomy:Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity:Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence:Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.

Leadership and Talent Management:May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience:Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Bachelors or higher in a degree in biotechnology, biology, or a closely related field. and minimum of 2 years of relevant experience.

EOE. Apply to Fax # 866-849-7714.

Job Title —Research and Discover Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

• Executing test protocols manually and recording the test results

• Creation/ Update of Master Validation Plan and other Validation documents for existing products.

• Active participation in the gap analysis, checking for documents in the system and creating new documents for Test Method, Test Method protocols and Validation Reports.

• Performing and documenting qualification and validation testing to accommodate process changes for existing product lines.

• Facilitating/participating in FMEA’s for existing production processes. Providing Support and implementing preventive actions and control plans to adequately address the FMEA result.

• Creation of Data analysis, Technical Reports for reduction of waste and increase in efficiency of the system.

Minimum Requirement:

Bachelor's degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, electrical engineering, engineering management, manufacturing engineering, or a closely related field.

EOE. Apply to Fax # 866-849-7714.

Job Title —Data Governance Consultant, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

The Data Governance program ensures that our company can find, understand, access and consume the data we need. As a magistrate of metadata for the Data Governance program, you will facilitate business and technical stakeholders in defining and owning our data assets. You will develop and enrich a data catalog as the authority for information about our data resources. Not only will you mentor our business leadership on their role in data governance, you will lead working groups to asses, define, classify, and steward new data assets, serving as the authority on metadata management. To this end, you will serve as an administrator of the Data Glossary system and ensure that metadata policies are followed and valuable to our company. By leading data governance efforts, you will work with all leaders and decision makers in the company and be a key partner in making data driven decisions in our company.

Key Responsibilities:

• Lead matrix teams for identification, classification, and rationalization of business, technical and operational metadata.

• Onboard and train individuals into data governance roles.

• Execute standards, policies, and processes regarding metadata management.

Skills and Experience:

• Bachelor's Degree and/or equivalent combination of education and experience preferred.

• 5 or more years of experience in Enterprise Information Management with GAAP or accounting data.

• Experience with metadata tools (Collibra, Informatica)

• Proficiency in business process requirements gathering and documentation

• Demonstrated experience in work estimation and management

• Experience with Master Data Management is desired

EOE. Apply to Fax # 866-849-7714.

Job Title —Executive Director, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

As we continue to grow in the processes it uses to grow it's business and keep up with technological advances, the company has an immediate need for an Executive Director. The Executive Director, hired to work alongside CEO, is primarily responsible for ensuring the mission of VAStek is achieved through heading up the Engineering functions of the organization, creating and maintaining the hiring and training regiments, maintaining client relationships with engineering firms, and reporting weekly to fellow Executives and the Board (as needed) regarding VAStek' s objectives and the pace of achievement. Will be responsible to work within the organization from it's very top and serve as a primary point of contact with leadership at client locations ensuring that all placed engineers are meeting the needs of the client, the primary point of contact with all training personnel to ensure that curricular and training meets the exacting standards of the company, and will oversee and manage all human resources professionals to ensure that hiring of engineers is both sufficient to meet the engineering needs and that the qualifications of the hired professionals are in alignment with existing and proffered contracts.

The position will be responsible for:Managing Human Resources, Training, and Sales teams, the leadership of whom will report directly to the beneficiary, ensuring the following:

HUMAN RESOURCES

• Making sure that the engineering backgrounds, education, and experience of hired personnel match the needs of engineering clients.

• Ensuring that those who recruit at universities, job fairs, etc. are fully conversant in the engineering needs of the company and its clients and are seeking a proper fit for those professionals required.

• Ensuring that the professionals hired who may need nonimmigrant visas have experience and education which fit their roles in the company.

• Manage teams of engineers by ensuring adequate placement of engineering professionals with firm clients.

TRAINING

• Ensure that the training personnel are correctly implementing the curricula enabling them to demonstrate the use and design of medical diagnostic and clinical instrumental ion, equipment, and procedures, using the principles of engineering and biobehavioral sciences.

• Ensure that the training personnel are fully certified as required and that the certification meets the exacting standards of Vastek and Vastek clients, as well as any regulatory requirements.

• Conduct periodic reviews of training manuals and curricula to ensure that they meet existing engineering requirements and protocols.

• Ensure that Vastek conducts training or in-services to educate fi rm employees on proper use, development, and maintenance of equipment.

SALES

• Ensure that sales professionals are fully conversant in engineering terms and fields, adapting as needed with the times, so that they can communicate effectively with engineering clients.

• Ensure that contracts proffered by sales professionals are for engineering services that Vastek is equipped to provide and that Vastek employees are available and adequately trained/educated to serve the customers' needs.

• Respond, as needed, to specific engineering needs brought by sales personnel or clients, ensuring that Vastek provide the engineering services required.

For each of these duties, the Executive Director will also have duties to report to myself as CEO and senior management at Executive and Board level, as needed. For this, the reports will vary from engineering specific to broader " big picture" analysis of the relevant programs and the seamless nature of Vastek operations.

This position, essential to the company’s corporate vision, relationships with important partners and client s, and to the ability of Vastek to grow, contains the type of highly specialized engineering analysis and understanding of global engineering needs that candidates are expected to have learned in the University setting.

Minimum Requirement: Masters's in Engineering

EOE. Apply to Fax # 866-849-7714.

Job Title —Chief Engineer Director, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Part-time.

Job Description:

• Ensure that the training personnel are correctly implementing the curricula enabling them to demonstrate the use and design of medical diagnostic and clinical instrumentation, equipment, and procedures, using the principles of engineering and biomedical sciences

• Ensure that the training personnel are fully certified as required and that the certification meets the exacting standards of VAStek and VAStek clients, as well as any regulatory requirements

• Conduct periodic reviews of training manuals and curricula to ensure that they meet existing engineering requirements and protocols

• Ensure that VAStek conducts training or in-services to educate firm employees on proper use, development, and maintenance of equipment.

• Ensure that sales professionals are fully conversant in engineering terms and fields, adapting as needed with the times, so that they can communicate effectively with engineering clients.

• Ensure that contracts proffered by sales professionals are for engineering services that VAStek is equipped to provide and that VAStek employees are available and adequately trained/educated to serve the customers' needs.

• Respond, as needed, to specific engineering needs brought by sales personnel or clients, ensuring that VAStek provide the engineering services required.

• Making sure that the engineering backgrounds, education, and experience of hired personnel match the needs of engineering clients.

• Ensuring that those who recruit at universities, job fairs, etc. are fully conversant in the engineering needs of the company and its clients and are seeking a proper fit for those professionals required.

• Manage teams of engineers by ensuring adequate placement of engineering professionals with firm clients.

Minimum Requirement: Bachelor's in Engineering

EOE. Apply to Fax # 866-849-7714.

Job Title —FT Director of Market Intelligence, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

Vastek seeks an FT Director of Market Intelligence for its San Diego office to analyze the market demand for different IT techs, study about them & advertisement on resource allocation to attract labor & clients, & analyze & recommend content for targeted marketing materials relating to the marketing of tech professionals in different IT verticals.MS in IT/Computer Science and 24 months as Tech Marketing Profession including 12-months experience in the marketing of tech professionals requirements.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

Job Title —Senior Manufacturing Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

Reports to the Engineering Supervisor. Responsible for the implementation of project and process support activities toward attainment of departmental and plant goals. Primary focus in areas of capacity expansion, quality/waste improvement, and cost improvement programs. Required to handle multiple assignments of varying scope and complexity.

Essential Functions –

Responsible for the design and implementation of machine improvements and capital equipment project management activities. Proficient in mechanical design and troubleshooting. Directs personnel in the troubleshooting and maintenance of cam-driven mechanisms and pneumatic and hydraulic equipment used in the production process. Supports the plant manufacturing effort, with proven ability to identify problems and pursue plans toward their resolution. Specific focus will be in areas of improving upon chronic levels of quality, waste and equipment efficiencies. A clear understanding of the role of Engineering in a manufacturing environment.

Has knowledge of proper Engineering practices and vendor relationships. Responsible for coordinating activities between equipment vendors, Division R & D and plant functional departments on his/her assignments. Ability to handle projects of a moderate to large scope requiring extensive coordination. Will be required to handle several assignments (project & process duties) simultaneously. Prepares and submits capital appropriation requests and controls expenditures on these projects as required. Has knowledge of established safety standards and operator interface with the equipment. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment. Recommends vendors for commercial items and materials needed for a project. Establishes which elements comprising a job are suitable for in-house fabrication or revision and which items would be best contracted. Secure quotations and select contractors; direct the contractor’s efforts or the efforts of in-house forces to the satisfactory scheduled completion of the necessary work. Supervise and inspect all work-in-process by contractors or plant forces; provide guidance where necessary.

Responsible for the recommendation of capital equipment or process modifications, their physical installation, debugging and associated training of production personnel. Required to have awareness of product performance and quality requirements within the scope of his/her assignments. As required within the scope of his/her duty, be responsible for all associated documentation, including; however not limited to, the following; validations, Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc. Required to develop a firm understanding of all equipment for which he/she is responsible to include set-up, adjustment, and assessment of possible improvements. Responsible for realization of budgeted cost reductions and productivity improvements. Accountable for spending (capital or expense) within approved limits on programs.

Additional Responsibilities –

Performs other duties as required by the Engineering Supervisor. Directs the efforts of support personnel such as machinists and technicians, etc. in the modification, adjustment, removal, and installation of new or existing equipment as required. May provide functional supervision of other Engineers toward attainment of his/her assignments.

Minimum Requirements-

Must have Bachelors Degree in Mechanical or Manufacturing Engineering. Must have a minimum of 5 years of work experience in a manufacturing environment. Must have high-speed automated assembly experience in the following areas synchronous and asynchronous assembly platforms cam-operated equipment pneumatics and servo controlled assembly. Understanding of Lean Manufacturing initiatives with an emphasis on continuous improvement. Six Sigma certification (greenbelt or black belt) preferred.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

Job Title —Quality Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

Quality Engineer with at least a BS / MS in Industrial Engineering / Mechanical Engineering along with with an ASQ Certified Quality Engineering (CQE) and at least 4+ years of work experience in the Medical Device industry. Quality Engineer will be responsible for providing Quality Engineering support as a member of the cross-functional team responsible for manufacturing operations. This role supports the production of surgical sutures and polymer-based components for endoscopic and stapling surgical instruments.

Primary Skills-

• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests, and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Validations and Measurement Systems Analysis (MSA).
• Work directly with component/raw material suppliers and Incoming Quality to include inspection plan creation and maintenance, PPAP (as applicable), and SCAR/NCR management.
• Process Validation and/or Root Cause Analysis experience
• Working knowledge of statistical methods and applications (Minitab experience a plus)
• Project management experience (familiarity with Microsoft Project – Gantt Charts).
• Familiarity with Lab operations/management.

Secondary Skills-

• ASQ Certified Quality Engineering (CQE)
• Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
• Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints
• Support reliability activities for new product development. Drive for root cause understanding and corrective action implementation to ensure the product meets reliability requirements
• Strong written and verbal communications (including presentation skills)
• Proficiency in Microsoft Project, Word, and Mini-tab

Educational Qualifications-

BS / MS in Industrial Engineering / Mechanical Engineering

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

Job Title —Sr. Packaging Engineer, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

This position will support all product packaging design, development, verification testing and sustaining activities for the AIM and MDIS business groups.

Responsibilities –

• Design and document new product packaging based on Marketing and interdepartmental core team requirements.
• Work with local suppliers to develop package designs, with emphasis on manufacturability, recyclability, alignment to global hazardous materials regulations, ease of assembly/use and cost containment.
• Authorship test plans, manage sample procurement and preparation, oversee test execution at a local test laboratory, and document test results in reports.
• Resolve packaging related rejections in RI for existing packaging components.
• Initiate ECRs/ECOs, provide packaging drawing redlines to drafting, and review incorporated drawings for completeness and accuracy.
• Execute and document design reviews as necessary.
• Present periodic project status reports to peers and senior leadership.

Educational Qualifications-Bachelor’s degree in Packaging Science, Engineering or equivalent.

Required Experience-Experience in commercial packaging design, medical device industry experience preferred. REQUIRED KNOWLEDGE:

• Must demonstrate a broad and extensive knowledge of packaging engineering design principles and materials.
• Understanding of ASTM test requirements and protocols
• Experience using Agile PLM and SAP ERP software
• Ability to write clear, concise test plans and reports
• Knowledge of materials, finishing processes, and manufacturing methods required to meet the package design requirements.
• Able to work with minimal supervision and can adapt to changing environments.

Desired/Preferred Qualifications (optional)

• Experience in ETO and E-Beam sterilization packaging design
• Experience in designing form/fill/seal pouches
• Knowledge of RoHS Reach and other global environmental and consumer safety regulations.
• Ability to use Solid-works and Auto CAD, CAD software, utilizing assembly configurations, part, assembly modeling techniques.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

Job Title —Product development engineer

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:

This position will support all Product development engineer, development, verification testing and sustaining activities.

Responsibilities –

• Work with Quality and R&D Engineers to review the product requirements, develop the process flow and coordinate with validation activities.
• Perform Dimensional Inspection of tools/equipment used in the product development.
• Writing Installation, Operational, Performance qualifications (IQ/OQ/PQ), TMV’s on process equipment as required, creating Engineering change orders and release designs for production with all necessary engineering documentation.
• Execute design of experiments, Process characterization and time studies as apart of product development process and draft Engineering test reports.

Educational Qualifications-Mechanical engineering or equivalent.

Required Experience–

• Experienced in Product Requirement Spec (Design Specifications), Quality Plan/Traceability Matrices, Risk Management File (Design FMEA, Hazard Analysis), Design History File (DHF)
• Experience in Statistical Process Control (SPC) Methodologies and best practices Experience using Agile PLM and SAP ERP software
• Ability to write clear, concise test plans and reports
• Knowledge of materials, finishing processes, and manufacturing methods required to meet the package design requirements.
• Able to work with minimal supervision and can adapt to changing environments.
• Work with Quality and R&D Engineers to review the product requirements, develop the process flow and coordinate with validation activities.
• Perform Dimensional Inspection of tools/equipment used in the product development.
• Writing Installation, Operational, Performance qualifications (IQ/OQ/PQ), TMV’s on process equipment as required, creating Engineering change orders and release designs for production with all necessary engineering documentation.
• Execute design of experiments, Process characterization and time studies as apart of product development process and draft Engineering test reports.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895