Quality Manager, Medical Devices & QMS Lead

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

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