Principal Quality Assurance Engineer
Core
Leads the entire design control process for medical devices, from validating design inputs to overseeing verification, validation, and design transfer, ensuring adherence to regulatory and quality standards.
Role type
Principal Quality Assurance Engineer (Medical Device)
Builds
Validated medical device designs and systems ready for production
Domain
Medical Device / Regulatory Quality Assurance
Required skills
Design control process management, statistical process validation, root cause analysis, CAPA management, risk management, usability validation, reliability assessment, performance validation, manufacturability validation, safety validation
Preferred skills
Medical device regulations and standards, Design for Quality, Post Market Surveillance (PMS) integration, data analysis
Technologies
Statistical tools, CAPA methodologies
Responsibilities
Plan and execute comprehensive process validation strategies using statistical tools; Lead the design control process including eliciting and validating design inputs; Conduct thorough assessments of product and system designs and perform root cause analysis; Lead quality improvement projects integrating PMS insights; Validate critical design inputs for usability, reliability, performance, manufacturability, and safety; Guide comprehensive risk management activities throughout the product lifecycle
Seniority
Principal, hands-on IC with strategic oversight