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Senior Quality Manager

San Carlos, CA

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Our client is seeking a Senior Quality Manager on the West Coast!

Our client is a pioneer in the food testing and analyzation industry and is enhancing the way food is tested and analyzed through breakthrough research and technology. Major brands are capitalizing on this new era of food safety technologies and the Senior Quality Manager will play an integral role in all aspects of developing and improving the quality department.

Specific Responsibilities:

  • Design & implement workflow for…
    • Product verification & validation
    • Employee training, certification, and records
    • Establishing product stability shelf-life
    • Product software validation
    • Equipment qualification and process validation
    • Process for product release prior to shipment
  • Move company into full FDA Quality System Requirement 21 CFR 820 compliances
  • Assess and develop quality process improvements

Qualifications:

  • Bachelor’s degree in science, engineering, or related field
  • 5+ year of experience as QA Manager or supervisor role in Medical Device Company
  • Experience with IVD (in-vitro diagnostic) products (preferred)
  • Knowledge of FDA QSR 21 CFR 820 and/or related ISO standards
  • Experience with IVD product launch via pre-market notification 510(k) or premarket approval (PMA) (preferred)
  • Supervisory and leadership skills
  • NPI & DFM concept familiarity
  • Phase-gate approach in product development familiarity