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Senior Quality Manager - Manufacturing
Job in
Littleton, Middlesex County, Massachusetts, 01460, USA
Listed on 2026-08-14
Listing for:
GCB Services
Full Time
position Listed on 2026-08-14
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
Operations Quality Manager
We are seeking an Operations Quality Manager for a manufacturing company in Littleton, MA. This role will own day-to-day manufacturing quality, lead the QC Supervisor and Quality Engineering team, and drive quality systems and continuous improvement initiatives.
Key Responsibilities
- Lead all manufacturing-related quality activities across production operations.
- Oversee in-process inspection, final inspection, product acceptance, and release activities.
- Manage Quality Engineers, the QC Supervisor, and inspection activities.
- Own the NCR/MRB process, including investigation, disposition, trending, and timely closure.
- Drive CAPA and corrective actions based on manufacturing quality trends and root cause analysis.
- 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 manufacturing and incoming material performance.
- Provide leadership with data-driven reporting on quality performance, risks, trends, and improvement initiatives.
- Coach and develop the manufacturing Quality team while helping build a strong culture of quality.
MUST HAVES:
- 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, with some prior medical device experience required.
- 3+ years managing Quality Engineers and/or QC teams.
- Experience owning Manufacturing Quality, NCR/MRB processes, and shop-floor execution.
- Strong knowledge of ISO 13485 and risk-based quality principles.
- Must be able to travel (5-10%) to support vendors, customer sites, troubleshooting, and system testing.
Benefits:
- Competitive compensation
- 10% annual target bonus
- Health, vision and dental insurance
- 401k retirement savings with match
- Life insurance
- Comprehensive paid leave
Position Requirements
10+ Years
work experience
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