Job Title —Data Governance Analyst, at Vastek Inc.

Company —Vastek Inc.

Location —San Diego, California.

Job type —Full-time.

Job Description:The Data Governance Lead will lead the development and implementation of an enterprise data governance program at OneAmerica. This individual will have the opportunity to establish the policies, standards, rules, processes and technologies to effectively manage OneAmerica data assets. This role will work closely with senior business and technology leaders to create a set of programs, disciplines and practices to significantly improve the ownership and quality of critical data.

Key Responsibilities:

  • • Chairs the Data Governance Council and handles communication and escalation to the Data Governance Executive Steering Committee. Schedules and facilitates Data Governance Council meetings with clear agendas. Establishes data governance priorities based on Data Governance Council input. Serves as an advocate for the Data Governance program and increases Data Governance awareness.
  • • Lead the development and implementation of the Data Governance organization structure within OneAmerica.
  • • Supports the Data Governance Executive Steering Committee which approves data policies, sets corporate and strategic vision for Data Governance, defines Data Governance strategy, provides Data Governance oversight, ensures enterprise alignment with Data Governance and Data Strategy, determines data project prioritization & funding, provides data domain sponsorship, provides conflict resolution.
  • • Responsible for implementing enterprise data governance processes to effectively govern enterprise data including the management of enterprise data governance, operating model, data policies and standards as well as the implementation of clearly defined data management definitions for use across the organization.
  • • Roll out an enterprise wise data governance framework, with a focus on improvement of data quality and the protection of sensitive data through modifications to organization behavior policies and standards, principles, governance metrics, processes, related tools and data architecture.
  • • Responsible for defining data modeling approach for conceptual, logical and physical data models.
  • • Oversee data modeling efforts and review data models.
  • • Provide support to business and technical stakeholders and participate in initiatives to define technical solutions to support business processes.
  • • Participate as an individual contributor on project teams to implement designs with application team.
  • • Define roles and responsibilities related to data governance and ensure clear accountability. In addition, he/she will have a key role guiding and influencing various stakeholders across the organization to achieve the goals defined in the enterprise data governance and enterprise data management strategies.
  • • Have oversight and ensure that standardized data governance "tools" including data requirements documents, data lineage work flows, metadata forms, data models, etc. are used across the organization by all relevant stakeholders.
  • Educational and Experience Requirements:Minimum Bachelor’s Degree in relevant field; Master’s Degree a plus

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


    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.


    Job Title —Validation Engineer

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    Vastek, Inc. in San Diego, CA is seeking Validation Engineers to perform validation and develop validation documents for Laboratory instrumentation by following approved Standard Operating Procedures (SOPs, current Good Manufacturing Practices (GMPs), and all other regulatory requirements. Duties and responsibilities will include:

    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).


    Job Title —Software Project Manager, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    We are seeking a Software Project Manager to join our team!You will be responsible for the management and delivery of technology related projects across various departments

    Responsibilities:

  • • Plan and implement large IT projects
  • • Direct and lead the work of technical staff
  • • Evaluate new IT strategies and procedures
  • • Ensure deadlines and cost targets are met
  • • Maintain required project documentation
  • • Serve as a liaison between business and technical aspects of projects
  • Qualifications and Experience:

  • • Previous experience in information technology or other related fields
  • • Strong project management skills
  • • Strong analysis and critical thinking skills
  • • Deadline and detail-oriented
  • • Strong leadership qualities
  • EOE. Apply to Fax # 866-849-7714.


    Job Title —Equipment Validation Engineer

    Job Description:

    Vastek, Inc. in San Diego, CA is seeking Equipment Validation Engineers to perform validation and develop validation documents for Laboratory instrumentation by following approved Standard Operating Procedures (SOPs, current Good Manufacturing Practices (GMPs), and all other regulatory requirements. Duties and responsibilities will include:

    • 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 Manufacturing Engineering, at Vastek Inc.

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    Vastek of San Diego seeks an FT Manufacturing Engineering Specialist to analyze the market demand for different contract manufacturing engineer personnel & use analysis of metrics & knowledge of manufacturing engineer principles, determine suitability & feasibility of specific employees for specific client requirements as well as the suitability of specific projects for fulfillment by company. Position requirements travel of 10+ weeks every quarter to field sites to analyze client needs. MS in Manufacturing/Industrial Engineer requirements.

    Fax resumes to 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

    Job Title —Design engineer

    Company —Vastek Inc.

    Location —San Diego, California.

    Job type —Full-time.

    Job Description:

    Responsible for the design, modeling, development and testing of a machine, structure or system. Develops functional requirements. Understands and applies standard engineering principles. Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates. Designs and tests components and integrates components to produce final product. Monitors quality of products and controls the efficiency of processes. Evaluates a design’s overall effectiveness, cost, reliability, and safety. Investigates root causes of failures to maintain quality and recommend improvements.

    Responsibilities –

    • Develops system level design strategies and may lead design, development, testing & refinement of components and sub-systems.
    • Development follows Invent It, Make It, Sell It procedures.
    • Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations and presents possible solutions.
    • Possesses and applies a broad knowledge of principles, practices, and procedures of a particular field of specialization to the completion of difficult assignments.
    • Reviews progress and evaluates results.
    • Recommends changes in procedures and processes.
    • Assignments are broad in nature, requiring originality and ingenuity.
    • Has appreciable latitude for unreviewed action or decision.
    • Guide and direct design engineers and senior design engineers in the same project.
    • Fundamental understanding of IPC and IEC requirements as well as ISO organization related to electrical.
    • Perform formal risk analysis and develop software mitigation. SW build, change control, and development/test process improvement.
    • Development of research prototypes used to evaluate new product concepts.
    • A desire to deliver a quality and innovative product that improves lives.
    • Contribute to the definition and specification of future designs.
    • Own/Support all phases of the product development lifecycle including design, implementation, debug, verification, validation, and transfer to manufacturing.

    Educational Qualifications-Bachelor’s degree in Software Engineering, Electrical Engineering, or related field. M.S. in Software Engineering, Electrical Engineering preferred.

    Required Experience–

    • Requires a minimum of 5 years experience.
    • Familiar with concepts of design input, design output, trace-ability, and risk analysis.
    • Able to debug software and hardware/schematics at higher level using logic analyzers, oscilloscopes, and simulators.
    • Experience in concurrent cross-platform development preferred.
    • Demonstrates mastery in system level software (drivers, RTOS, and test applications) in embedded environment.
    • Expertise in debugging embedded systems without or with little emulator support.
    • Understands product development processes including: Change Control & Design Control. Software Development Life Cycle . Fluent in: C/C++, Object Oriented Coding, Windows Embedded Agile Testing Tools: Code Warrior, Perforce or similar, Doxygen, Lab View, Matlab, Microsoft Visual Stud. Knowledge in embedded system design required. Understand integration of software and hardware required.
    • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
    • Must possess excellent oral and written communications.

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

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