Medical Device Quality Engineer
Core
Provide Quality Assurance support and guidance to ensure compliance for combination products and biological therapeutics.
Role type
Medical Device Quality Engineer
Builds
Combination products for biological therapeutics
Domain
Biopharmaceuticals / Medical Devices
Required skills
Design and Development documentation review, Design Verification/Validation/Transfer, Risk Management (FMEA), Statistical analysis, Test method validation, Change assessment, Regulatory compliance, Quality procedure writing
Preferred skills
Experience with combination products or medical devices
Technologies
FMEA, Statistical controls, Hypothesis testing
Responsibilities
Review Design and Development documentation for compliance, Support Design Verification/Validation/Transfer, Lead Risk Management activities, Coordinate test method development and validation, Justify statistical analysis, Support complaint and test failure investigations, Write Quality Procedures
Seniority
Associate (0-2 yrs), Engineer (2 yrs), Senior (5+ yrs)