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    Senior Director - Oklahoma City, United States - LDI Group Inc

    LDI Group Inc
    LDI Group Inc Oklahoma City, United States

    1 day ago

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    Description

    Senior Director – Site Quality Operations

    Our client is dedicated to developing innovative solutions that significantly improve patient care, contributing to a healthier society. As a leading player in specialized diagnostics on a global scale, they operate through direct and distributor markets, boasting technology hubs in Europe and the US with annual sales exceeding $2 billion.

    • Opportunity to drive meaningful growth for a quality leader
    • Lead all site quality functions and ensure compliance with regulatory bodies
    • Reporting to the Executive VP of Global QA & RA
    • Enhancing business tools and systems integration
    • Managing a quality team of approximately 50 members
    • Maximizing potential across various quality areas such as QMS, Validation, Document Control, Quality Engineering, and Compliance

    Requirements:

    • Bachelor's Degree in Engineering or Life Science
    • Minimum of fifteen years' experience in regulated industries
    • Prior leadership role in quality or regulatory functions within diagnostics or medical devices
    • Proficiency in US FDA Quality System Regulations, ISO 13485, EU MDR, and IVDR
    • Strong communication, negotiation, and conflict resolution skills
    • Proven ability to develop compliant systems in evolving regulatory environments
    • Background in continuous improvement and change management within manufacturing

    This position offers substantial visibility and growth prospects in the long term. If you are ready to embrace a challenging and rewarding opportunity, we invite you to further explore this role.



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