Senior Engineer, Advanced Quality
Core
Senior Quality Engineer driving reliability, human factors, risk management, and design validation for new medical device development to ensure regulatory compliance and safe product launch.
Role type
Senior IC quality engineer (medical devices)
Builds
New medical device products and manufacturing processes
Domain
Medical devices / Regulatory compliance
Required skills
Risk management, Design validation, Human factors engineering, Regulatory compliance (FDA/ISO), Root cause analysis, Statistical methods, Design reviews, Process controls, Inspection planning, Problem solving
Preferred skills
Medical device product development lifecycle experience, Risk management and design/process verification and validation
Technologies
Quality engineering tools, Statistical methods, Design development methods, Process development and control methods
Responsibilities
Define design requirements and develop manufacturing processes for new products; Lead risk management and human factors engineering studies; Guide NPD teams through quality system requirements; Evaluate residual risk and present risk/benefit justification; Lead design validation efforts; Support design transfers and predicate device evaluation; Develop quality assurance documentation for regulatory submissions; Lead NC & CAPA activities.
Seniority
Senior, hands-on IC