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Senior Quality Manager - Manufacturing
Job in
Littleton, Middlesex County, Massachusetts, 01460, USA
Listed on 2026-08-17
Listing for:
Straffing AI
Full Time
position Listed on 2026-08-17
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Compensation: $145,000–$175,000 + 10% annual target bonus
Industry: Medical Devices / Advanced Manufacturing
Travel: 5-10%
Relocation Assistance: Not provided
About the OpportunityLocation: Littleton, MA
Work Arrangement: On-site
Experience: 8+ years
Compensation: $145,000–$175,000 + 10% annual target bonus
Industry: Medical Devices / Advanced Manufacturing
Travel: 5-10%
Relocation Assistance: Not provided
We are seeking a Senior Quality Manager
- Manufacturing to lead quality operations for a manufacturing organization in the medical-device industry.
This role will own day-to-day manufacturing quality, lead Quality Engineering and QC teams, and drive quality systems, compliance, and continuous improvement across production operations.
What You’ll Do- Lead manufacturing quality activities across production operations.
- Oversee in-process inspection, final inspection, product acceptance, and release activities.
- Lead and develop Quality Engineers, QC leadership, and inspection teams.
- Own the NCR/MRB process
, including investigation, disposition, trending, and closure. - Drive CAPA and corrective actions using root-cause analysis and manufacturing quality trends.
- Lead continuous improvement initiatives focused on quality, yield, efficiency, and risk reduction.
- Apply Lean, Six Sigma, and other process-improvement methodologies.
- Support new product, equipment, and manufacturing process introductions through quality planning and risk management.
- Ensure compliance with FDA QMSR, ISO 13485
, and applicable international regulations. - Support internal and external audits, including FDA and notified-body inspections.
- Partner with Manufacturing, Engineering, Supply Chain, and Operations to resolve quality issues and improve processes.
- Support supplier-quality activities related to incoming materials and manufacturing performance.
- Provide leadership with data-driven reporting on quality performance, trends, risks, and improvement initiatives.
- Coach and develop the Quality team while strengthening a culture of quality throughout manufacturing.
- Travel approximately 5–10% to support vendors, customer sites, troubleshooting, and system testing.
Required:
- Bachelor's degree in Engineering
- Mechanical, Electrical, or related discipline, or equivalent experience and training. - 8+ years of progressive Quality experience in medical device, aerospace, defense, or IVD manufacturing.
- Prior medical-device experience is required.
- 3+ years of experience managing Quality Engineers and/or QC teams.
- Demonstrated ownership of Manufacturing Quality, NCR/MRB processes, and shop-floor quality execution.
- Strong knowledge of ISO 13485 and risk-based quality principles.
- Experience with CAPA, root-cause analysis, audits, and continuous improvement.
- Ability to travel 5-10% as required.
- $145,000–$175,000 base compensation
- 10% annual target bonus
- Health, dental, and vision insurance
- 401(k) with company match
- Life insurance
- Comprehensive paid leave
- Flexible working environment
Position Requirements
10+ Years
work experience
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