Quality Senior Engineer
Core
Develop and apply quality control systems, analyze manufacturing processes, and implement improvements to ensure product functionality and safety for end customers.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Quality systems, validated processes, and compliant manufacturing procedures for medical products.
Domain
Medical devices / Healthcare manufacturing
Required skills
Root cause analysis, Lean tools, Risk assessment, Statistical analysis, Process validation, ISO standards compliance, Project management, Technical writing, Change management, 5S methodology
Preferred skills
CQE certification, Product transfer experience, New procedure definition
Technologies
IQ/PPQ/IOQ protocols, PFMEA, NCR systems, OT Core System
Responsibilities
Evaluate and implement high-complexity process improvements, support root cause investigations for non-conformances, develop and approve quality plans and validation protocols, coach team members on quality standards, ensure EHS compliance and area cleanliness.
Seniority
Senior, hands-on IC