【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: ．Responsible for quality oversight and execution and prepare inspection criteria and standards for the assigned projects throughout the product lifecycle and the associated Quality System. Provide QA Approvals/Perspectives as needed. ．Proactively engage with all stakeholders involved with product quality and design transfer. ．Coordinate and oversight the change control process to ensure the process and records are appropriate and accurate. ．Responsible for customer complaint, product return/repair (RMA) and investigations in accordance to client or regulator’s requirements. ．Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports. ．Able to coordinate for tool validation activities and supplier evaluation. ．Able to support process improvements by gap analysis of existing SOPs or processes against up-to-date standards and regulations and updates accordingly. ．Other duties as assigned.