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    Online Director - Boston, MA, United States - Connect Life Science

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    Description
    Contract Quality Director

    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.

    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.
    engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures
    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

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