【QA-生醫】品保工程師/資深工程師Quality Assurance Engineer/Senior Engineer(台北/新竹)

工作詳細內容Job descriptions：

Responsibilities & Authorities: • Provide quality assurance support throughout product development and pilot build phases, ensuring compliance with applicable quality standards and regulations. • Review and approve design-related documentation, including specifications, verification/validation protocols, and reports. • Participate in design transfer activities, ensuring quality requirements are met during transition from development to manufacturing. • Coordinate and manage change control processes, ensuring documentation accuracy and traceability. • Support investigation and resolution of product-related issues, including customer complaints and RMA cases, in accordance with regulatory and client requirements. • Review and approve deviations, CAPAs, risk assessments, and nonconformance reports related to development and pilot production. • Collaborate with cross-functional teams to ensure quality perspectives are integrated into product development decisions. • Conduct gap analysis of existing procedures and support updates to align with current standards (e.g., ISO 13485, ISO 14971). • Assist in supplier evaluation and tool validation activities as needed. • Other duties as assigned to support quality and regulatory compliance.