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

Quality Manager (5 Yrs. Medical Device QM & QC Exp. Req.)
Location: Billerica MA (on-site)
Salary: $135000 - $150000 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 manufacturers product quality compliance and operational excellence.

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

Lead and continuously improve the companys 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 Bachelors 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