Quality Engineering Manager
Core
Lead and standardize Quality Engineering activities across multiple manufacturing sites producing medical devices, driving investigations, CAPA, and regulatory compliance.
Role type
Senior Quality Engineering Manager (Manufacturing)
Builds
Medical device components (bloodlines, tubing systems, accessories) for dialysis therapy
Domain
Healthcare / Medical Devices / Manufacturing
Required skills
Manufacturing/Process Engineering leadership, Medical device quality systems (ISO 13485, EU MDR, FDA 21 CFR Part 820), Root cause analysis (8D, DMAIC), Risk management (PFMEA, ISO 14971), Process validation, Statistical analysis
Preferred skills
Minitab, Injection molding/Extrusion/Automation knowledge, Lean Six Sigma Green/Black Belt
Technologies
Minitab, ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971, MDSAP
Responsibilities
Lead and standardize Quality Engineering activities across multiple manufacturing sites, Drive investigation and resolution of complex product and process quality issues, Provide technical leadership for CAPA and nonconformance processes, Analyze quality data to identify systemic issues, Lead cross-functional teams for quality improvements, Support new product introductions and design/manufacturing transfers, Ensure compliance with ISO 13485, EU MDR, and FDA regulations
Seniority
Senior, hands-on IC with leadership responsibilities