We at Siemens Healthineers? are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
What are my responsibilities?
1. Coordination of and contribution to solve quality problems according to e.g. 8D-methodology and drive projects to solve the problems sustainably.
依據(jù)質(zhì)量方法（例如：8D）持續(xù)推動(dòng)項(xiàng)目進(jìn)行，協(xié)調(diào)解決質(zhì)量問題；"
2. Training and guidance of internal colleagues and Suppliers with the target to get a solid performance
培訓(xùn)指導(dǎo)內(nèi)部員工、供應(yīng)商，使他們獲得良好的表現(xiàn)；"
3. Timely tracking SCM and supplier related regulation( at least including ISO 13485, ISO 9001,QSR 820,China GMP,Australia TGA 1989 and 2002,Brazil ANVISA RDC16/2013,Japan MHLW NO.169 , Canada CMDR ,EU MDD, MDR), analysis and planning of implementation and lead implementation
及時(shí)跟蹤全球生產(chǎn)和供應(yīng)商相關(guān)法規(guī)（至少包括ISO 13485, ISO 9001,QSR 820,China GMP,Australia TGA 1989 and 2002,Brazil ANVISA RDC16/2013,Japan MHLW NO.169 , Canada CMDR ,EU MDD, MDR)， 分析并制定執(zhí)行計(jì)劃并領(lǐng)導(dǎo)導(dǎo)入計(jì)劃的執(zhí)行；
4. By coach, mainreview, training, review, communiation, influence, and other necessary skills to the SCM teams , to make sure the high quality output of products（including documents and records） and make sure the product compliance with related regulation, standards and customer requirements，and signature and release of product and process ECO as independent controller.
通過對供應(yīng)鏈團(tuán)隊(duì)的指導(dǎo)，培訓(xùn)，審核，主評(píng)審，溝通，影響和 其它需要之方法， 以實(shí)現(xiàn)SCM高質(zhì)量的產(chǎn)品輸出（包括文檔和記錄），同時(shí)確保產(chǎn)品對法規(guī)、標(biāo)準(zhǔn)和客戶要求的滿足, 并作為獨(dú)立監(jiān)管員簽署并發(fā)布放行產(chǎn)品和生產(chǎn)過程的變更。
5. Planning,prepare and reply for SCM and supplier related issues during external audit, including: FDA, CFDA, MDSA audit, NB audit,etc.
外部審核時(shí)，負(fù)責(zé)SCM和供應(yīng)商相關(guān)任務(wù)的計(jì)劃、準(zhǔn)備和回答，審核包括 FDA, CFDA, MDSA audit, NB audit,etc.
6. Responsible for product deviation and NC control as indepent controller
作為獨(dú)立監(jiān)管員負(fù)責(zé)產(chǎn)品偏差和不合格品的管理；"
7. Production final inspection accurance for product release
產(chǎn)品終檢放行。"
8. Authority:Quality Coaches in matters of quality issues. Intervene, overrule and escalate in the case of non-conformity of regulations. Escalation for decision of stop of deliveries and services. Unrestricted access to all quality relevant data.
權(quán)限：對質(zhì)量事務(wù)提供質(zhì)量指導(dǎo)。介入，統(tǒng)籌處理并報(bào)告不符合法規(guī)的事件。向中止產(chǎn)品發(fā)貨或服務(wù)的決策過程進(jìn)行報(bào)告。有權(quán)獲得所有質(zhì)量相關(guān)數(shù)據(jù)。
What do I need to qualify for this job?
1. University degree or adequate
2. Experience in Quality system management
3. Good knowledge of ISO9001, ISO 13485, FDA regulations
4. Excellent consultation skills
