【QA-生醫】專案品保(有害物質)工程師 (台北/新竹)

工作詳細內容Job descriptions： Responsibilities & Authorities: 1. Reponsible for Hazardous Substances Management System including: − Periodically update the applicable regulations (RoHS/REACH/SVHC/POPs/ED/PFAS/BPA/Latex/EU - CMR/Cal Prop 65) for medical devices. − Capable of conducting risk assessment and evaluating the impact of new or revised regulations/standards. − Collect and obtain the declaration, report, or evidence from Suppliers for compliance. − Establish and manage the hazardous Substance Database. − Complete the hazardous substances information for components and products approval. 2. Responsible for quality oversight and execution for medical devices during the product lifecycle and the associated Quality System. 3. Work on assigned projects as the QA representative to support the business to ensure the design control process, activities, risk management process and design history files (DHF) are in compliance with internal QMS and regulatory requirements. − Proactively engage with all stakeholders involved with product quality and design transfer. − Responsible for process validation activities incl. tool validation for medical devices. Able to coordinate for tool validation activities with suppliers. − Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports. − Coordinate and oversight the change control process to ensure the process and records are appropriate and accurate. − Handle product complaint/inquiry requests or investigations in accordance to client or regulator’s requirements. 4. Owns and maintain Quality Key Performance Indicators (KPIs) for area of expertise. 5. Other duties as assigned. 負責有害物質管理系統，包括定期更新醫療器材適用之法規標準，具備針對新制定或更新之法規與標準之風險分析與影響評估，蒐集供應商端的符合性宣告/報告/或相當證據證明符合性，建立與維持有害物質資料庫。 負責確校活動審查，例如模具/製程確校，輔導與教育外包供應商，符合內部規範。 負責相關事務之異常偏差、矯正行動與風險評估等。支援所指配專案的品質活動或其他臨時指派事項。