Quality Manager

Goddard; Wilmington (MA); On-site; USD 105,000 - 135,000; Full time

Benefits offered by this job

Flexible Time Off

Retirement Savings: 401(k) plan with 3

Health Coverage: medical/dental/vision

Family Support: 6 weeks parental leave

Company Engagement: events and outings

Job summary

Goddard is seeking a Quality Manager to lead and continuously improve the ISO 13485:2016 certified QMS for medical device design and development. You will build and guide the quality team, ensure compliance with FDA and international requirements, and partner with engineering, program management, and clients from concept through design transfer.

The role requires overseeing design controls, risk management, internal audits, and external inspections, while driving CAPA, documentation, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s preferred.
• 7+ years of quality experience in medical devices including 3+ years in design or product development.
• 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, IEC 62366-1, and IEC 60601-1 series; preferred certifications.

Responsibilities

• Maintain and improve the certified QMS per ISO 13485:2016, 21 CFR Part 820 (QMSR), and EU MDR as required.
• Ensure design controls across all development programs; manage Design History Files.
• Lead risk management per ISO 14971:2019 and integrate with design activities.
• Lead internal audits and host external audits, including FDA inspections and supplier audits.
• Own CAPA, nonconformance, and change control processes; drive root-cause analysis.
• Oversee document control, records management, and training program.
• Manage supplier controls, including supplier qualification and performance monitoring.
• Partner with clients on quality agreements and quality plans.
• Oversee calibration and equipment maintenance and support method validation.

Skills

Quality management

Leadership

Regulatory compliance

Communication

Time management

Education

Bachelor’s Degree in Engineering or Life Sciences

Master’s degree preferred

Job description

Our Mission

Through inspired engineering and design, we deliver outstanding solutions that positively impact lives. We use an interdisciplinary development process that combines our diverse engineering experience with creative industrial design solutions. We succeed when our partners succeed – it’s all about solving the most complex challenges by creating transformative technology.

Our Mission

Through inspired engineering and design, we deliver outstanding solutions that positively impact lives. We use an interdisciplinary development process that combines our diverse engineering experience with creative industrial design solutions. We succeed when our partners succeed – it’s all about solving the most complex challenges by creating transformative technology.

Our Culture And People

At Goddard, our most important asset is our people. We don't just work together; we thrive together. We foster a culture of collaboration, continuous learning, and mutual support. We believe in taking exceptionally good care of each other because great teams build great solutions. If you are someone who embodies the values of accountability, inspiration, dedication, efficiency, innovation, integrity, quality, and reliability, we want you on our team. Come be a part of a workplace where your ideas are valued, your growth is encouraged, and your contributions make a real impact. Join us in shaping the future of transformative technology – together.

The Role

• 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

• 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.

Qualifications

• 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.

Our Benefits

• 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.

The Pay Range For This Role Is

105,000 - 135,000 USD per year(Wilmington Office)