Senior Quality Assurance Manager
Listed on 2026-08-20
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Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Senior Manager, Manufacturing Quality | Greater Boston
X4 Life Sciences are proud to be partnered with a fast-growing Medical Device organisation in the Greater Boston area that is looking to hire a Senior Manager, Manufacturing Quality. This is a fantastic opportunity to join an innovative organisation developing highly complex medical device products, working within a low-volume, high-complexity capital equipment manufacturing environment.
The Senior Manager, Manufacturing Quality will take ownership of manufacturing quality operations, ensuring robust quality execution across the production floor while driving continuous improvement initiatives to improve product quality, efficiency, and risk reduction. Reporting into the Director of QA/RA, this role will work closely with Manufacturing, Engineering, Supply Chain, and Operations leadership, acting as the key quality partner across manufacturing activities.
Key Responsibilities- Lead all manufacturing quality activities across production operations
- Own shop-floor quality execution, including in-process inspection, final inspection, and product release activities
- Provide quality decision-making related to product acceptance, deviations, nonconformances, and risk
- Own NCR and MRB processes, ensuring timely investigation, disposition, and closure
- Drive CAPA activities and continuous improvement initiatives based on quality trends
- Lead manufacturing process improvements focused on quality, efficiency, yield, and risk reduction
- Manage and develop a team of Quality Engineers and QC professionals
- Support internal and external audits, including FDA and notified body inspections
- Partner cross-functionally with Manufacturing, Engineering, Supply Chain, and Operations teams to embed quality throughout production
- 8+ years of Quality experience within Medical Device manufacturing or similarly regulated industries
- 3+ years managing Quality Engineers, QC teams, or manufacturing quality functions
- Experience owning Manufacturing Quality, NCR/MRB processes, and shop-floor quality execution
- Strong knowledge of ISO 13485, FDA Quality System Regulations (QMSR), and risk-based quality principles
- Experience with low-volume, high-complexity manufacturing environments preferred
- Experience with complex electromechanical products or capital equipment highly desirable
- Bachelor’s degree in Engineering (Mechanical, Electrical, Manufacturing, or related discipline)
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