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.
依據質量方法（例如：8D）持續推動項目進行，協調解決質量問題；"
2. Training and guidance of internal colleagues and Suppliers with the target to get a solid performance
培訓指導內部員工、供應商，使他們獲得良好的表現；"
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
及時跟蹤全球生產和供應商相關法規（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)， 分析并制定執行計劃并領導導入計劃的執行；
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.
通過對供應鏈團隊的指導，培訓，審核，主評審，溝通，影響和 其它需要之方法， 以實現SCM高質量的產品輸出（包括文檔和記錄），同時確保產品對法規、標準和客戶要求的滿足, 并作為獨立監管員簽署并發布放行產品和生產過程的變更。
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，負責SCM和供應商相關任務的計劃、準備和回答，審核包括 FDA, CFDA, MDSA audit, NB audit,etc.
6. Responsible for product deviation and NC control as indepent controller
作為獨立監管員負責產品偏差和不合格品的管理；"
7. Production final inspection accurance for product release
產品終檢放行。"
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.
權限：對質量事務提供質量指導。介入，統籌處理并報告不符合法規的事件。向中止產品發貨或服務的決策過程進行報告。有權獲得所有質量相關數據。
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
