4 days old

Senior Quality Operations Engineer

Lodi, CA 95240


Support manufacturing, contract manufacturing, and complaint handling/field sustaining leading to improved compliance with corporate policies, 21CFR820, ISO 13485, the Medical Device Directive, and other applicable regulatory agencies, while striving for continuous improvement.

NPI and Change Control Activities:

  • Ensure that DMRs are complete and accurate as part of NPI/design transfer to manufacturing.
  • Review ECOs and deviations according to change order guidelines, ensuring impact for Major change(s) is outlined and evidence of required activities, and reason for change is clear and accurate.
  • Ensure maintenance of validated state, and consideration for re-validation during various design and process changes.
  • Ensure maintenance of product ID and traceability, including that of safety critical parts.
  • Review and approve the criteria for WIP reworks and re-inspections.
  • Drive improvements in process capability and quality of products.

    Failure investigations and corrective actions:

    • Regularly monitor, investigate and review nonconformance activities and generate CAPAs/SCARs based on trends/issues identified from operations, MRB and drive them to closure.
    • Investigate failures for field/customer, in-coming and in-process problems and execute corrective actions.
    • Proactively identify potential problems and drive continuous improvement, utilizing the CAPA/SCAR and other processes.

      Process Validation and Manufacturing Process Support

      • Provide support to process validation and other processes on the manufacturing floor, warehouse and facilities as required.

        Quality System Support:

        • Support global initiatives/QSIPs and ensure that required activities are carried out, including pertinent personnel planning, training and resourcing.

          All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

          Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology


Posted: 2020-05-21 Expires: 2020-06-20

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Senior Quality Operations Engineer

Lodi, CA 95240

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