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    Sr. QA Manager - Manila, Philippines, Pilipinas - MICHAEL PAGE INTERNATIONAL RECRUITMENT (PHILIPPINES) INC.

    MICHAEL PAGE INTERNATIONAL RECRUITMENT (PHILIPPINES) INC.
    MICHAEL PAGE INTERNATIONAL RECRUITMENT (PHILIPPINES) INC. Manila, Philippines, Pilipinas

    6 araw ang nakalipas

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    Buong oras
    Paglalarawan
    • Global leader in innovation, design, & manufacturing of medical devices
    • Senior leader in the local manufacturing site

    About Our Client

    A global leader in innovation, design, manufacturing and selling of custom made, approved and clinically validated medical devices.

    Job Description

    • Enhance the Quality Management System (QMS) and manufacturing controls/processes to constantly monitor and ensure quality and continuous improvement.
    • Communicate with in-house employees and external vendors/consultants to build, enhance, and ensure quality awareness and regulatory compliance.
    • Ensure the proper interface of the quality function to product development (R & D), manufacturing, supply chain, and other areas, as required.

    The Successful Applicant

    • Relevant Tertiary education with a Bachelor's Degree in a scientific discipline, preferred within the medical Device Industry.
    • Broad understanding of key elements of RA and QA
    • Working within an ISO 13485 / MDSAP Quality Management System is essential
    • Knowledge of US FDA21 CFR 820 Quality Systems Regulation is desirable
    • Knowledge and experience of the medical device EU CE marking process and MDD/MDR is essential
    • Knowledge of the US FDA product approval process e.g. 510k is desirable
    • Knowledge of other regional quality & regulatory obligations is desirable
    • Experience of Class I and II / IIa devices is essential
    • 5 to7 years of experience, with responsibility for full spectrum of QA in a medical device company
    • Experience in working in a global and complex environment, in a stand-alone role.

    What's on Offer

    • Competitive Package
    • Flexible work arrangements
    • Autonomy
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