Senior Quality Engineer: TMV & PFMEA Lead (Medical Devices)

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    Skills

    • Cross-Functionalunmatched
    • Documentationunmatched
    • Establish Prioritiesunmatched
    • FDA Requirementsunmatched
    • ISO (International Organization for Standardization)unmatched
    • Manufacturingunmatched
    • Medical Equipmentunmatched
    • Process Failure Mode and Effects Analysis (PFMEA)unmatched
    • Quality Engineeringunmatched
    • Quality System Requirements (QSR)unmatched
    • Research & Development (R&D)unmatched

    Description

    Pentangle Tech Services | P5 Group is seeking a senior Quality Engineer to support post-acquisition remediation with a strong focus on PFMEA and TMV. You will evaluate legacy documentation, identify gaps, and drive remediation to align with ISO 13485, ISO 14971, and FDA QSR requirements.The role prioritizes cross-functional collaboration with R&D, Manufacturing, and the Quality team to ensure seamless integration of acquired processes into the existing QM system.#J-18808-Ljbffr

    Numbers & Facts

    LocationIrvine, CA

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