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. Need strong quality baseline and rich coaching and influencing skill to guide the high quality SCM output and always need to overcome the challenges from limited resource and boundary of responsibilities( from personal and department ) with experienced constructive solutions.
需要堅守質量底線，通過豐富的指導和影響力來確保生產輸出的高質量，常常需要克服由有限的資源和個人以及部門責任邊界所帶來的挑戰，并且需要提出建設性意見的能力；
2. Timely track global QMS related regulation, analysis and planning of implementation and lead implementation.
及時跟蹤全球各國質量體系相關法規， 分析并制定執行計劃并領導導入計劃的執行；
3.Establish, maintain and optimize management related process, at least including audit, management review, document management, quality manual, process indicator, role deion, training, statistics, NP software validation, outsource etc.
建立、維護和優化管理相關的程序，至少包括：審核，管理評審，文件控制，質量手冊，過程監控，角色定義，培訓，NP軟件確認，外包控制等；
4. 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；
5. Organize and lead external audit, including: FDA, CFDA, MDSA audit, NB audit,etc.
組織并領導外部審核，包括 FDA, CFDA, MDSA audit, NB audit等；
6. Responsible for product deviation and NC control as independent controller.
作為獨立監管員負責產品偏差和不合格品的管理；
7. Training of internal colleagues with the target to get a solid performance
培訓內部員工，使他們獲得良好的表現；
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. Good knowledge on QMS related regulation and standards and have experience to implemented into QMS, at least - ISO 13485, ISO 9001- QSR 820- China GMP MDD including.
具備豐富的質量體系相關法規和標準的知識，并且具備將之導入質量體系的經驗，至少包括:ISO 13485, ISO 9001- QSR 820- China GMP MDD；
2. Have solid experience in application of Q-methods and statistics, e. g. SPC, MSA, APQP.
具備豐富的質量方法和統計（例如：SPC、MSA、APQP等）應用經驗；
3. English ：smoothly communicate in listening, oral, write.
流利的英語聽說讀寫能力