Senior Quality Manager - Manufacturing

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.