Senior Quality Leader - Medical Devices & Compliance

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

Job summary

Motion Recruitment Partners is seeking a Quality Manager to lead the quality function for a medical device-focused firm. The role oversees an ISO 13485:2016 QMS, ensuring compliance with FDA requirements and ISO standards, and partners with engineering and product development across the lifecycle.

The ideal candidate will have 7+ years in medical device quality, hands-on QMS management, CAPA leadership, and a track record of guiding design controls and audits.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 7+ years of quality experience within the medical device industry.
• 3+ years in medical device design, engineering, or product development environment.
• 2+ years of people management or team leadership experience.
• Hands-on experience maintaining an ISO 13485:2016 QMS.
• Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 14971:2019, and medical device design controls.
• Experience leading design controls including DHFs and design transfer.
• Experience with internal audits and external audits including FDA inspections.
• CAPA, nonconformances, change control, root-cause analysis, continuous improvement.

Responsibilities

• Lead and continuously improve the ISO 13485:2016 QMS.
• Serve as Management Representative and maintain certification through audits.
• Ensure design controls are applied across development programs.
• Oversee design and development planning, inputs/outputs, reviews, V&V, and transfer.
• Manage risk management and ensure DHFs are integrated.
• Lead internal audits and be the primary contact for external audits and regulatory inspections.
• Establish quality objectives, metrics, and management reviews.
• Own CAPA, nonconformance, and change control processes.
• Oversee document control, training, and supplier quality programs.
• Collaborate with clients on quality agreements and product transfer to manufacturing partners.
• Oversee calibration, equipment maintenance, and test method validation.
• Hire, develop, and mentor the quality team.

Skills

QA leadership

QMS

Regulatory compliance

CAPA management

Design controls

FDA inspections

Audits

Risk management

Communication

Team mentoring

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree (preferred)

Job description

Motion Recruitment Partners is seeking a Quality Manager to lead the quality function for a medical device-focused firm. The role oversees an ISO 13485:2016 QMS, ensuring compliance with FDA requirements and ISO standards, and partners with engineering and product development across the lifecycle.

The ideal candidate will have 7+ years in medical device quality, hands-on QMS management, CAPA leadership, and a track record of guiding design controls and audits.