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.
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Pay: $150,000.00 - $170,000.00 per year
Benefits:
- 401(k) matching
- Health insurance
- Life insurance
Education:
Experience:
- Quality : medical device, aerospace, defense, IVD manuf.: 8 years (Required)
- Quality Engineers and/or QC teams: 8 years (Required)
- Manufacturing Quality, NCR/MRB processes: 8 years (Required)
- ISO 13485 and risk-based quality principles: 8 years (Required)
- support vendors, customer sites, troubleshooting: 8 years (Required)
Work Location: On the road
