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    Senior Director - New York, United States - LDI Group Inc

    LDI Group Inc
    LDI Group Inc New York, United States

    3 weeks ago

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    Description
    Senior Director – Site Quality Operations

    Our client started with a mission to develop meaningful innovations that truly enhance patients care, creating a healthier society.

    They are a world leader in specialized diagnostics, operating globally via direct and distributor markets with technology centers in Europe and the US driving sales north of $2 billion pa.


    To continue their desired growth, we are supporting them in the search for a Senior Director -Site Quality Operations based Middlesex County MA.

    This is a fantastic platform for continued career development for a quality leader seeking a challenging opportunity, the chance to make a real business impact and to enhance their career.


    This role will be responsible for leading all site quality functions as well as fulfilling quality assurance obligations to appropriate regulatory bodies, serving as the Management Representative.


    Reporting to the Executive VP of Global QA & RA, with a quality team of circa 50 this role will be tasked with driving improvements across the quality organization, enhancing business tools, integrating systems, succession planning, taking the team to maximize potential across all areas of QMS, Validation, Document Control, Quality Engineering, Compliance etc.


    Do you have:
    Bachelor's Degree (Engineering or Life Science) required.
    Fifteen (15) years' relevant experience in medical devices or other regulated industry.
    Previous experience in a quality or regulatory leadership position in a diagnostic or medical device manufacturer required.
    Expert level understanding of US FDA Quality System Regulations, ISO 13485, in EU MDR and IVDR.
    Excellent presentation, negotiation, conflict resolution skills with strong written/verbal communication skills across leadership levels.
    Ability to identify opportunities for creating compliant systems in a new, rapidly changing product and regulatory environment.
    Demonstrated continuous improvement, change management exposure Quality organization in a manufacturing environment.

    This will be a highly visible role with long-term growth opportunities.

    If you have the drive, mentality and expertise to take on a new, exciting opportunity please reach out for further information and a conversation.

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