Quality Engineering Manager
Core
Lead quality incident investigations, supplier quality management, and regulatory compliance for medical device manufacturing processes.
Role type
Senior Quality Engineering Manager
Builds
Quality control systems, validation studies, and compliance frameworks for medical devices
Domain
Medical Device Manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality incident investigation, Corrective and Preventive Actions (CAPA), Supplier quality management, Validation study design, FMEA, MSA, Statistical process control, Regulatory compliance (ISO 13485/MDR/NMPA), Team leadership, Performance management
Preferred skills
Six Sigma, Risk analysis based on manufacturing experience
Technologies
ISO 13485, MDR, QMSR, NMPA, FMEA, MSA, CAPA
Responsibilities
Lead quality incident and complaint investigations and define corrective/preventative actions; Manage supplier and intercompany quality performance; Oversee generation and review of validation studies, capability studies, and control plans; Develop quality metrics to track performance and drive improvements; Ensure compliance with regulatory requirements (ISO 13485/MDR/QMSR/NMPA); Enforce occupational health and safety standards
Seniority
Senior, hands-on IC with management responsibilities