Senior Engineer, Quality Assurance
Core
Lead Emergency Care critical investigations and drive improvements to ensure quality excellence and patient safety across the product lifecycle.
Role type
Senior Quality Assurance Engineer
Builds
Medical device products ensuring compliance and safety
Domain
Medical Devices / Quality Assurance
Required skills
Root cause analysis, statistical evaluation, risk assessment, corrective and preventive action (CAPA) management, audit coordination, regulatory compliance knowledge
Preferred skills
Six Sigma Green Belt, ISO 14971, ISO 13485, 21 CFR Part 820, EU MDR experience, product field action experience
Technologies
ISO 14971, ISO 13485, 21 CFR Part 820, EU MDR
Responsibilities
Lead product field action assessments, investigate complex product quality issues, perform post-market health risk assessments, develop containment recommendations, manage nonconformance records, coordinate cross-functional reviews, represent QA during audits
Seniority
Senior, hands-on IC