Design Quality Assurance Engineer II
Core
Ensure patient safety and product excellence by supporting commercialized medical devices through design strategy, risk management, and lifecycle quality activities.
Role type
Design Quality Assurance Engineer II
Builds
Commercialized medical devices (ICVT division)
Domain
Medical device industry / Quality Engineering
Required skills
Risk management, Design controls, Product verification and validation, Global quality system regulations, Statistical analysis, Design History File management, Field performance monitoring
Preferred skills
Biomedical or mechanical engineering background, Cardiovascular/implantable device experience, Quality engineering certification (CQE), Advanced quality tools
Technologies
ISO 14971, ISO 13485, FMEA, Fault Tree Analysis, Hazard Analysis
Responsibilities
Resolve complex product and process quality issues across the product lifecycle, Provide quality engineering assessment on new product development teams, Drive implementation of risk management activities, Develop verification and validation protocols and reports, Establish and maintain Design History File documentation, Monitor field performance of medical devices and drive corrective actions
Seniority
Mid-level, hands-on IC