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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(fù)責(zé)人一起開(kāi)發(fā)，建立和維護(hù)，并優(yōu)化統(tǒng)一的CAPA流程，滿足包括內(nèi)部和外部質(zhì)量法規(guī)認(rèn)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(lái)源并監(jiān)控升級(jí)的問(wèn)題。

--Regularly report the CAPA status to the management/定期報(bào)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(zhì)量管理指南對(duì)CAPA流程進(jìn)行例行的內(nèi)部評(píng)估，并直接向持續(xù)質(zhì)量改進(jìn)主管匯報(bào)改進(jìn)建議及改進(jìn)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(guān)的人員培訓(xùn)CAPA和解決問(wèn)題的意識(shí)，知識(shí)和工具以使開(kāi)展CAPA更暢順。

-- Work together with process owner for the CAPA/和流程負(fù)責(zé)人一起制定糾正預(yù)防措施
-- Verify the CAPA for the non-compliance findings./驗(yàn)證不符合項(xiàng)的糾正預(yù)防措施



2. Internal auditor/內(nèi)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(zhì)量程序是否符合相關(guān)標(biāo)準(zhǔn),法規(guī)和西門子醫(yī)療質(zhì)量規(guī)定.

2) Performed the audits as planed to check whether the SSMR-MR quality regulations are followed effectively/按計(jì)劃執(zhí)行內(nèi)審,檢查SSMR-MR質(zhì)量規(guī)定是否有效地實(shí)施.


3. Statistical technique application/統(tǒng)計(jì)技術(shù)應(yīng)用

1) Establish, maintain and optimize statistical technique application process and ensure the process and implementation comply with regulation requirements./建立、維護(hù)和優(yōu)化統(tǒng)計(jì)技術(shù)應(yīng)用流程，確保流程和實(shí)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(guān)專業(yè)本科學(xué)歷

-At least 5 years experience for quality management
5年及以上質(zhì)量管理經(jīng)驗(yàn)

-Profess. Know.: Fluent in English (spoken and written)/流利的英文（聽(tīng)說(shuō)讀寫(xiě)）
-Medical device product knowledge/醫(yī)療器械產(chǎn)品知識(shí)

-Procedure