Quality Engineer, Test Method Validation (TMV)
Core
Develop, validate, and maintain test methods to verify product quality and ensure compliance with regulatory and industry requirements for high-precision dispensing devices.
Role type
Quality Engineer (Test Method Validation)
Builds
Validated test methods, protocols, and measurement systems for manufacturing equipment and processes.
Domain
Healthcare manufacturing / Quality Engineering / Metrology
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
None stated
Technologies
Minitab, JMP, Microsoft Office
Responsibilities
Draft and execute complex validation plans and protocols; Perform measurement system analysis and capability studies; Conduct risk assessments (FMEA) for processes and equipment; Train personnel in quality and TMV principles; Support Engineering in equipment selection and upgrade; Develop audit responses and complete CAPAs; Identify root causes of test method failures and modify methods accordingly.
Seniority
Mid-level, hands-on IC
