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    Quality Manager, Medical Device Company - San Diego, United States - Ignite Human Capital

    Ignite Human Capital
    Ignite Human Capital San Diego, United States

    3 weeks ago

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    Description


    We are excited to share a new Quality Manager position with one of San Diego's best small medical device firms.

    They are on the move and ready for the next phase of growth, and this position is vital to the company.

    The perfect candidate would be able to lead a team of 2-3 people while remaining hands-on.

    The company has a very close culture and the people are kind, easy to work with and dynamic in their respected fields.

    Here is more about the role;


    POSITION SUMMARY:


    As an integral member of the Leadership Team, the Quality Manager assumes the role of Management Representative according to ISO 13485 standards.

    This position requires a dynamic individual who will serve as the Subject Matter Expert in Quality, providing regular updates to Executive Management on the status of the Quality Management System (QMS).

    The ideal candidate will be hands-on, proactive, and collaborative, dedicated to ensuring compliance with regulatory standards and fostering a culture of quality excellence within the organization.


    ESSENTIAL RESPONSIBILITIES:
    Serve as the Management Representative, ensuring the adequacy and compliance of the QMS with all relevant regulatory standards.
    Mentor and develop the Quality Staff, fostering a culture aligned with the company's core values.

    Oversee all QMS activities, including but not limited to training, customer feedback management, deviations, corrective actions, supplier quality, and change control.

    Exercise judicious budget management in Quality operations.
    Provide expertise in quality assurance judgment and assessments.
    Continuously enhance the QMS to adapt to evolving business needs.
    Lead the Company Quality Objectives and facilitate their achievement.
    Conduct audits from regulatory agencies and ensure compliance with ISO 14971 for risk management.
    Drive quality actions based on data analysis from internal manufacturing, customer feedback, and device performance.
    Lead internal, external, and supplier audit activities.
    Manage quality plans and oversee the review and approval of components and finished products.


    EDUCATION/EXPERIENCE REQUIREMENTS:
    Bachelor's degree in life science or related field, engineering, or scientific discipline preferred.
    Minimum of 7 years of quality experience in medical device, IVD, or biotech industries.
    At least 3 years in a leadership and direct line management role.
    Demonstrated competency in QMS governance and standards.
    Ability to thrive in a small to medium-sized early-stage commercial business environment.


    KEY QMS GOVERNANCE and STANDARDS:


    Expertise in relevant regulations including 21 CFR Part 820, ISO 13485, MDD, MDR, MDSAP, ISO 14971, cGDP, GMP, and 5S principles.


    PHYSICAL DEMANDS & WORK ENVIRONMENT:
    Regular communication and occasional lifting of up to 25 pounds may be required.
    Work primarily in a general office environment with exposure to PCs and networks.
    Moderate noise level in the work environment.
    Travel may be necessary.

    COMPENSATION:
    Between $115-140K base, plus bonus - with title and compensation level depending on experience.

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