Senior Quality Manager - Manufacturing

Job Description:

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
• Flexible working environment