工作詳細內容Job descriptions： QA Engineer/Senior Engineer: (1名) 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. 工作詳細內容Job descriptions： Responsibilities & Authorities: 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. 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。 Responsible for process validation activities incl. tool validation for medical devices. Able to coordinate for tool validation activities with suppliers. 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。 Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports. Able to support quality assurance activities for assigned projects. Other duties as assigned. 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。

工作詳細內容Job descriptions： Responsibilities & Authorities: 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. 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。 Responsible for process validation activities incl. tool validation for medical devices. Able to coordinate for tool validation activities with suppliers. 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。 Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports. Able to support quality assurance activities for assigned projects. Other duties as assigned. 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。