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    Quality Director - Boston, United States - Connect Life Science

    Connect Life Science
    Connect Life Science Boston, United States

    2 weeks ago

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    Description

    Position:
    Contract Quality Director


    Location:
    Boston – Hybrid

    Duration: 12 Months Contract


    Our client are bringing a class III device to the market and are seeking a Quality Director who is a critical thinker, data driven, and quality minded.

    You'll ensure compliance to ISO13485 and FDA Quality Systems Regulations.

    You'll be the main points of contact for FDA and other regulatory agencies for all Quality Management Systems aspects of the business.


    Job Responsibilities:
    direct and control the company's quality engineering departments
    device quality assurance activities in accordance with (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements)
    action and quality improvement activities.
    in technical discussions with suppliers to identify and implement improvements in products and processes.
    engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures
    budgets


    Experience:
    years in Quality Assurance within medical device
    in Engineering or technical field
    of FDA regulations, and the Quality Systems Regulation, and EN ISO 13485:2016 are essential
    managing teams within the Quality Management System
    managing audits from regulatory authorities

    Interviews taking place week commencing 29th April, please apply early to discuss this position.

    #J-18808-Ljbffr

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