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(Sr.) Quality Engineer - CAPA (高級) 質(zhì)量工程師
面議 深圳 應(yīng)屆畢業(yè)生 本科
  • 全勤獎
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西門子(深圳)磁共振有限公司 2026-02-08 20:44:54 586人關(guān)注
職位描述
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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(fù)責(zé)人一起開發(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(zhì)量管理指南對CAPA流程進(jìn)行例行的內(nèi)部評估,并直接向持續(xù)質(zhì)量改進(jìn)主管匯報改進(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(fù)責(zé)人一起制定糾正預(yù)防措施 -- Verify the CAPA for the non-compliance findings./驗證不符合項的糾正預(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/按計劃執(zhí)行內(nèi)審,檢查SSMR-MR質(zhì)量規(guī)定是否有效地實施. 3. Statistical technique application/統(tǒng)計技術(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)計技術(shù)應(yīng)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(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 -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(chǎn)品知識 -Procedure
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地址:深圳南山區(qū)深圳-南山區(qū)西門子(深圳)磁共振有限公司
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