Senior Quality Engineer - Waltham - Lumicell

    Lumicell
    Lumicell Waltham

    5 days ago

    Description

    Senior Quality Engineer

    Lumicell is revolutionizing cancer surgery, starting with breast cancer. Our mission-driven start-up environment offers a unique opportunity to work alongside high-performing employees tackling some of the most important challenges in cancer surgery.

    About the Role:

    • Owning and maintaining Complaint Handling, CAPA, and Document Control processes ensuring compliance with FDA regulations and ISO standards from clinical development through commercial launch.
    • Leading post-market quality activities including complaint intake investigation trending signal detection assess MDR reportability field actions corrective actions as needed.
    • Serving as a key Quality partner supporting pharmacovigilance clinical activities adverse event assessment safety documentation coordination internal stakeholders external safety vendors ensuring compliant safety reporting for combination products.

    Requirements:


  • Work in company

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  • Work in company

    Senior Quality Engineer

    Only for registered members

    At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery.  We are working to revolutionize the way cancer surge ...

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