Quality Manager

United States·Wilmingtonmid

Manufacturing & ProductionQuality Manager

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Quick Summary

Key Responsibilities

Maintain and improve the certified QMS in compliance with ISO 13485:2016 and 21 CFR Part 820 (QMSR), and EU MDR 2017/745 where client programs require it.

Requirements Summary

Maintain and improve the certified QMS in compliance with ISO 13485:2016 and 21 CFR Part 820 (QMSR), and EU MDR 2017/745 where client programs require it.

Technical Tools

Manufacturing & ProductionQuality Manager

Goddard Product Development (GPD) is seeking a Quality Manager to lead and continuously improve our ISO 13485:2016 certified Quality Management System (QMS), which supports the design and development of medical devices for our clients. The Quality Manager will build and lead the quality team, ensure our development work meets FDA and international requirements, and serve as a quality partner to engineering, program management, and clients from concept through design transfer.

Responsibilities

~2 min read

→Maintain and improve the certified QMS in compliance with ISO 13485:2016 and 21 CFR Part 820 (QMSR), and EU MDR 2017/745 where client programs require it. Serve as Management Representative and maintain certification through registrar surveillance and recertification audits.
→Ensure design controls are applied across all development programs, including design and development planning, design inputs and outputs, design reviews, verification and validation, design transfer, and complete Design History Files (DHFs).
→Oversee risk management per ISO 14971:2019, ensuring risk management files are integrated with design activities.
→Lead the internal audit program and host external audits, including registrar audits, client supplier audits, and FDA inspections.
→Establish quality objectives and metrics for monitoring QMS effectiveness and enabling sound product quality decisions; prepare and lead management reviews.
→Own the CAPA, nonconformance, and change control processes; lead or facilitate root-cause analysis to identify effective corrective actions and process improvements.
→Oversee document control, records management, and the training program.
→Manage supplier controls, including supplier qualification, the approved supplier list, performance monitoring, and audits of critical suppliers.
→Partner with clients on quality agreements, quality plans, and transfer to their manufacturing partners.
→Oversee calibration and equipment maintenance programs, and support test method validation and process validation (IQ/OQ/PQ) during transfer to manufacturing.
→Hire, develop, and manage the quality team, including performance management.

Requirements

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Bachelor’s Degree in Engineering, Life Sciences, or a related field; Master’s preferred
7+ years of quality experience in the medical device industry, including 3+ years in a design or product development environment
2+ years of people-management experience
Hands-on experience with ISO 13485, 21 CFR Part 820 (QMSR), ISO 14971, and design controls
Experience hosting FDA inspections and/or notified body audits
Familiarity with IEC 62304 (software), IEC 62366-1 (usability), and the IEC 60601-1 series (electrical safety) preferred
ASQ CQE, CQM/OE, or CBA certification, or ISO 13485 Lead Auditor, preferred
Strong communication (written and verbal), collaboration, decision-making, and problem-solving skills.
Thorough and results-driven, with excellent organizational and time-management skills.

What We Offer

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Flexible Time Off: Benefit from our generous flexible time off policy. We also provide sick leave and bereavement time because we understand that not all time off is for fun.

Retirement Savings: Invest in your future with a 401(k)-retirement plan. Goddard contributes 3% of your annual salary directly into your 401(k) account—regardless of your own contributions.

Health Coverage: Access to comprehensive medical, dental, and vision insurance for you and your family. Goddard contributes 80% of monthly premiums for all medical plan options.

Family Support: To take the time you need to welcome the newest member of your family, Goddard offer 6 weeks fully paid parental leave with support of PFML state programs.

Company Engagement: Engage with your colleagues through a variety of regular company and team events, including weekly social hours, Athletic Club outings, and department outings.