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    Director of Quality - Atlanta, United States - EPM Scientific

    EPM Scientific
    EPM Scientific Atlanta, United States

    1 day ago

    Default job background
    Description
    Director of Quality - Med Device

    Location:
    Raleigh, NC

    Working situation:
    Hybrid

    Level:
    Director
    Our client, a large, successful med device company and is looking to add to their Quality team
    The

    Director - Quality Assurance

    will help lead the Quality department and oversee all aspects of Quality Assurance.

    This individual will work to foster a culture of quality through providing leadership and guidance to their team and company.


    The Director - Quality Assurance will:
    Establish and maintain quality management systems (QMS) in accordance with ISO 13485 and other relevant standards.
    Identify, direct, and monitoring FDA and ISO audits, both internal and external, and assist with supplier audits
    Manage and mentor Quality management staff to promote personnel development and succession planning.
    Responsible for reviewing and delivering Quality Budget
    Collaborate cross-functionally with R&D, manufacturing, clinical affairs, and other departments to support product development, manufacturing, and commercialization activities.

    Drive a culture of quality and regulatory compliance throughout the organization, promoting awareness and understanding of quality and regulatory requirements among all employees.

    The Director - Quality Assurance has the following qualifications:
    Bachelor's Degree in Biology, Chemistry, Engineering, or related fields
    Minimum of 10 years of Quality experience in the Med Device industry 7-10 years of management experience
    In-depth knowledge of relevant regulations and standards, including FDA QSR, ISO 13485, MDR, and other global regulatory requirements.
    Strong leadership and management skills, with the ability to inspire and motivate teams to achieve results.

    Company Benefits:
    Competitive 401K program, health insurance, and HSA accounts
    Long term incentives in the terms of equity or stock at this level
    Flexible hybrid working model

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