Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.)
Location: Billerica, MA (on-site)
Salary: $135,000 - $150,000 + Benefits
Benefits: Medical, Dental, Vision, Disability, Life Insurance, 401K w/ Match, PTO, Sick Days
Job Type: Full-Time 
Typical Hours: Flexible 8-hour day, Monday-Friday between 7am-6pm
Start Date: ASAP
Sponsorship: Not Available
Relocation Assistance: Not Available

Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Description

Our client, a manufacturer serving the medical industry, is seeking a Quality Manager to join their team in Billerica, MA. This role leads a small, collaborative team while remaining hands-on approximately 70% of the time, focused on daily quality activities and 30% on planning, metrics, and reviews. The company recently completed an FDA audit and maintains a well-established Quality Management System focused on continuous improvement. The ideal candidate brings strong experience in both Quality Management and Quality Control within the medical device industry, with a deep understanding of ISO Quality Systems, FDA, GMP, and QSR requirements. Success in this role requires a leader who enjoys balancing floor-level engagement with strategic oversight in a metric-driven environment. This is a great opportunity to contribute directly to a respected manufacturer’s product quality, compliance, and operational excellence.

Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Responsibilities

•    Lead and continuously improve the company’s Quality Management System (QMS)
•    Ensure all products meet customer, technical, and regulatory requirements
•    Own the Non-Conformance (NCR) process and reporting 
•    Manage CAPA from root cause through verification 
•    Oversee Quality Control functions, including incoming inspection and calibration reporting
•    Conduct and prepare for internal and external audits, ensuring timely responses to findings
•    Serve as the site Management Representative for audits and regulatory interaction
•    Develop and maintain SOPs, work instructions, and QC checklists
•    Administer the complaint handling system with timely responses
•    Define quality requirements for new products and projects
•    Track and present key quality metrics in management review meetings
•    Promote a culture of quality and continuous improvement

Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Qualifications

•    Associate or Bachelor’s degree in engineering or another technical field is required
•    5+ years of combined Quality Management & Quality Control with medical devices is required
•    Experience with ISO 13485, FDA QSR, and GMP standards is required
•    Quality audit experience is required
•    Proficiency with Electronic Quality Management Systems (eQMS) required