【QA-醫療電子】產品驗證經理/資深經理 Product Verification Manager/ Sr. Manager (新竹)

Responsibilities & Authorities: • Lead and manage Product Verification Team for medical devices. • Provide the verification strategy for projects. • Reponsible for and continuously improve Design Verification & Validation planning, execution, and reporting process. • Oversight the testing program cross the sites. • Ensure the products in compliance with industry standards and regulations. • Develop and implement comprehensive testing protocols, analyze test results, and provide detailed reports. • Collaborate with other departments to address quality issues or debug issue. • Communicate with Customers for testing protocol, criteria, and report. • Train and mentor team members. • Have the experience in EMC, Safety, Reliability, debug, and provide the consultancy for problem solution. • Coordinate the resources and planning the outsourcing (3rd party) for Biocompatibility Testing / Sterilization Validation in regulated environment. • Manage the testing labs and plan for lab certification or procedure. • Manage and monitor dept KPI to be achieved and budget planning.