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Areas of Responsibilities:

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(fā)，建立和維護，并優(yōu)化統(tǒng)一的CAPA流程，滿足包括內部和外部質量法規(guī)認證的要求及符合西門子醫(yī)療流程框架。

2) Has an overall view of all CAPA sources and monitor escalated topics./了解所有CAPA數(shù)據(jù)來源并監(jiān)控升級的問題。

--Regularly report the CAPA status to the management/定期報告CAPA管理現(xiàn)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(jù)西門子醫(yī)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(xù)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(guī)和西門子醫(yī)療質量規(guī)定.

2) Performed the audits as planed to check whether the SSMR-MR quality regulations are followed effectively/按計劃執(zhí)行內審,檢查SSMR-MR質量規(guī)定是否有效地實施.


3. Statistical technique application/統(tǒng)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(yōu)化統(tǒng)計技術應用流程，確保流程和實施符合法規(guī)要求。


Education and Experience:

-Bachelor degree on Engineering, or other relevant qualification.
工程或其他相關專業(yè)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(yī)療器械產品知識

-Procedure