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 IC Quality Engineering Manager (Manufacturing)
Builds
Medical device components (bloodlines, tubing systems, accessories) for dialysis therapy
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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 problem-solving, Cross-functional team leadership
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, Support customer complaint investigations, Lead cross-functional teams for quality improvements, Support new product introductions and design transfers, Drive continuous improvement initiatives for defect prevention and yield improvement
Seniority
Senior, hands-on IC with leadership responsibilities