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Buena Park

    Quality Engineer - Buena Park, United States - Katalyst HealthCares & Life Sciences

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    Description

    Responsibilities:
    Test Method Validation and Process Validation in support of design transfer and production transfer.

    Measurement System Analysis (MSA) & Gage R&R (repeatability & reproducibility)

    Process risk documentation, including updates to PFMEAs.

    Team communications

    Other duties, as required.

    Requirements:

    5+ years of relevant Quality Engineering experience in the medical device industry

    Strong understanding of and extensive experience planning, executing and documenting test method validation and process validation in the medical device industry

    Measurement System Analysis and Gage R&R expertise

    Excellent verbal and written communication skills, including proven experience creating and updating validation and risk documentation and specific experience writing PFMEA content

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