Quality Assurance Manager

Our client is one of the top distributors within the alternate site market in the US. They are looking for a Quality Manager to join their team in the Boston area.

This is an excellent opportunity to join a client who are going through an exciting growth period, offering an excellent culture and long-term progression.

The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving our clients Quality Management System (QMS). This role ensures compliance with ISO 13485:2016, applicable regulatory requirements, and OEM quality agreements, while supporting the strategic growth and service expansion. The Quality Manager will serve as the primary owner of quality processes, audits, recall management, and risk management activities across the organization.

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field (or equivalent experience).
• 3+ years of experience in Quality Management within the medical device industry.
• Demonstrated experience managing and maintaining an ISO 13485:2016 compliant Quality Management System.
• Strong knowledge of audits, CAPA management, risk management (FMEA), training documentation, and document control.
• Excellent communication, organizational, and leadership skills.

• Experience supporting or managing 510(k) submissions.
• Working knowledge of ISO 9001.
• Experience in service, repair, or post-market medical device environments.
• Prior experience building or scaling a Quality function or department.
• Strong attention to detail and regulatory rigor
• Ability to balance compliance with operational efficiency
• Proactive problem-solving and risk-based thinking
• Collaborative leadership and cross-functional communication