Principal Quality Engineer - Marlborough - Altimeter Solutions

    Altimeter Solutions
    Altimeter Solutions Marlborough

    4 days ago

    Description

    Principal Quality Engineer

    This role ensures that Company IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.

    • Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations for IVD products
    • Conduct hazard analysis risk assessments for IVD products according to ISO14971 throughout the lifecycle

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