Quality Manager, Medical Devices & QMS Lead

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

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.