TMV Quality Engineer
Core
Develop, validate, and maintain test methods to verify product quality and ensure compliance with regulatory and industry requirements for medical devices.
Role type
Quality Engineer (Test Method Validation)
Builds
Validated test methods, protocols, and measurement systems for medical device manufacturing
Domain
Medical device manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Test Method Validation (TMV), Measurement System Analysis (MSA), Gauge R&R, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, Lean Manufacturing, Six Sigma, statistical software (Minitab/JMP), GMP compliance, audit preparation
Preferred skills
Experience with change control, deviation management, CAPA, technology transfer, cross-functional team leadership
Technologies
Minitab, JMP, Microsoft Office
Responsibilities
Design and execute TMV protocols for new and modified test methods; perform MSA, Gauge R&R, and capability studies; contribute to risk assessments (FMEA); validate test equipment, fixtures, and software; develop audit responses and complete CAPAs; support Engineering and Metrology in system selection and upgrades; train personnel in quality principles.
Seniority
Mid-Senior, hands-on IC
