Quality Manager

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

Benefits offered by this job

Flexible time off

401(k) retirement plan with company %

Health coverage for family

Parental leave

Team engagement events

Job summary

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

You will own CAPA, audits, design controls, risk management, and supplier controls while mentoring a growing quality group.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field; master’s preferred.
• 7+ years quality experience in medical devices; 3+ years in design or product development.
• 2+ years people-management experience.
• Hands-on 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, IEC 60601-1 preferred.
• ASQ CQE/CQM/OE or CBA certification, or ISO 13485 Lead Auditor preferred.

Responsibilities

• Maintain and improve the QMS in compliance with ISO 13485 and 21 CFR Part 820.
• Ensure design controls across development programs and manage DHFs.
• Oversee risk management per ISO 14971 and integrate with design activities.
• Lead internal audits and host registrar, supplier, and FDA audits.
• Establish quality objectives, metrics, and management review processes.
• Own CAPA, nonconformance, and change control processes with root-cause analysis.
• Manage document control, records, and training programs.
• Oversee supplier controls and supplier qualification and audits.
• Partner with clients on quality agreements, plans, and transfer activities.
• Oversee calibration, equipment maintenance, and test method validation.
• Hire, develop, and manage the quality team.

Skills

Leadership

Quality systems

Regulatory compliance

Cross-functional collaboration

Problem solving

Documentation

Audit coordination

Education

Bachelor’s Degree in Engineering or Life Sciences

Master’s preferred

Tools

ISO 13485

21 CFR Part 820 (QMSR)

ISO 14971

Design controls

IEC 62304

IEC 62366-1

IEC 60601-1

Job description

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.

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)