Quality Manager - Billerica; Medical Device QM & QC Exp Req
Listed on 2025-12-05
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Quality Assurance - QA/QC
Quality Control / Manager, QA Specialist / Manager
Quality Manager - Billerica (5+ Yrs Medical Device QM & QC Exp Req, $135K-$150K)
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 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.
Salary: $135,000 - $150,000 + Benefits
Job Type: Full‑Time
Typical
Hours:
Flexible 8‑hour day, Monday‑Friday between 7am‑6pm
Start Date: ASAP
Relocation Assistance: Not Available
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
- Associate or Bachelor’s degree in engineering or another technical field is required
- 5+ years of combined Quality Management & Quality Control experience 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) is required
Seniority level: Mid‑Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Medical Equipment Manufacturing
Benefits- Medical insurance
- Vision insurance
- 401(k)
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