Roles & Responsibilities

• Develop and write clear and detailed TMV protocols, test procedures, validation plans, and final reports


• Define acceptance criteria and ensure alignment with regulatory and quality requirements


• Interpret engineering drawings, specifications, and test methods to design validation approaches


• Perform and analyze Gage R&R studies to assess measurement system capability


• Select appropriate measurement tools and ensure accuracy of inspection methods


• Collaborate closely with Engineering, Quality, Operations, and R&D teams to support validation activities


• Ensure all documentation is audit-ready and compliant with ISO standards and medical device regulatory requirements


• Support training of operators, engineers, and quality personnel on validated inspection m...