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    Quality Manager - San Diego, United States - Johnson Service Group

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    Description

    Job Description

    Job Description

    Johnson Service Group, a nationally award-winning staffing firm, is looking to hire a Quality Manager for a privately held commercial medical device company in San Diego.

    This role is Direct Hire | Onsite | Candidate must have authorization to work with in the US as our client cannot offer current or future sponsorship.

    Position Summary:
    As a vital member of the Leadership Team, the Quality Manager acts as the Management Representative in accordance with ISO 13485 standards. This dynamic role requires a hands-on, proactive, and collaborative individual who will serve as the Subject Matter Expert in Quality. The Quality Manager will regularly update Executive Management on the status of the Quality Management System (QMS), ensuring compliance with all regulatory standards and promoting a culture of quality excellence within the organization.

    Responsibilities:

    • Serve as the Management Representative, ensuring the QMS meets 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 training, customer feedback management, deviations, corrective actions, supplier quality, and change control.
    • Manage the Quality budget efficiently.
    • Provide expertise in quality assurance judgments and assessments.
    • Continuously improve the QMS to adapt to evolving business needs.
    • Set and achieve Company Quality Objectives.
    • Lead and facilitate 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.
    • Oversee quality plans and manage the review and approval of components and finished products.

    Education/Experience:

    • Bachelor's degree in life sciences, engineering, or a related field (scientific discipline preferred).
    • Minimum of 7 years of quality experience in the medical device, IVD, or biotech industries.
    • At least 3 years in a leadership and direct line management role.
    • Proven competency in QMS governance and standards.
    • Ability to thrive in a small to medium-sized early-stage commercial business environment.
    • Expertise in relevant regulations, including 21 CFR Part 820, ISO 13485, MDD, MDR, MDSAP, ISO 14971, cGDP, GMP, and 5S principles.

    #D800

    ** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

    Company DescriptionOur people and culture make JSG a great place to work. We are all about growing and investing in our staff. JSG's mission is to empower people, help our clients reach their goals, and hire motivated individuals.

    We offer medical, dental, vision, life insurance options, paid time off, sick time, 401(k), weekly pay, and more.

    Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG

    We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs.

    Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

    Company Description

    Our people and culture make JSG a great place to work. We are all about growing and investing in our staff. JSG's mission is to empower people, help our clients reach their goals, and hire motivated individuals.\r
    \r
    We offer medical, dental, vision, life insurance options, paid time off, sick time, 401(k), weekly pay, and more.\r
    \r
    Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG\r
    \r
    We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs.\r
    \r
    Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

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