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Areas of Responsibilties: 1. CAPA Representative / CAPA代表 1) Develop, establish, maintain and optimize a CAPA process together with the process owner, including required certifications based on internal and external quality regulatory related requirements and in alignment with the Siemens Healthineers Process Framework. /與流程負責人一起開發，建立和維護，并優化統一的CAPA流程，滿足包括內部和外部質量法規認證的要求及符合西門子醫療流程框架。 2) Has an overall view of all CAPA sources and monitor escalated topics./了解所有CAPA數據來源并監控升級的問題。 --Regularly report the CAPA status to the management/定期報告CAPA管理現況 --Regular internal assessments for CAPA process based on Siemens Healthineers quality management guidelines. Direct report to the CQI team leader with recommendation of improvement actions and their follow up controlling./根據西門子醫療質量管理指南對CAPA流程進行例行的內部評估，并直接向持續質量改進主管匯報改進建議及改進措施跟蹤情況. 3) Train CAPA and problem solving mindset, knowledge and tools to related persons to facilitate CAPA process smoothly./向相關的人員培訓CAPA和解決問題的意識，知識和工具以使開展CAPA更暢順。 -- Work together with process owner for the CAPA/和流程負責人一起制定糾正預防措施 -- Verify the CAPA for the non-compliance findings./驗證不符合項的糾正預防措施 2. Internal auditor/內審員 1) Check whether SSMR-MR quality regulations are compliance with the standards, regulations and Siemens Healthineers QRs./檢查SSMR-MR的質量程序是否符合相關標準,法規和西門子醫療質量規定. 2) Performed the audits as planed to check whether the SSMR-MR quality regulations are followed effectively/按計劃執行內審,檢查SSMR-MR質量規定是否有效地實施. 3. Statistical technique application/統計技術應用 1) Establish, maintain and optimize statistical technique application process and ensure the process and implementation comply with regulation requirements./建立、維護和優化統計技術應用流程，確保流程和實施符合法規要求。 Education and Experience: -Bachelor degree on Engineering, or other relevant qualification. 工程或其他相關專業本科學歷 -At least 5 years experience for quality management 5年及以上質量管理經驗 -Profess. Know.: Fluent in English (spoken and written)/流利的英文（聽說讀寫） -Medical device product knowledge/醫療器械產品知識 -Procedure