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(jiān)守質(zhì)量底線，通過(guò)豐富的指導(dǎo)和影響力來(lái)確保生產(chǎn)輸出的高質(zhì)量，常常需要克服由有限的資源和個(gè)人以及部門責(zé)任邊界所帶來(lái)的挑戰(zhàn)，并且需要提出建設(shè)性意見(jiàn)的能力；
2. Timely track global QMS related regulation, analysis and planning of implementation and lead implementation.
及時(shí)跟蹤全球各國(guó)質(zhì)量體系相關(guān)法規(guī)， 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；
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(hù)和優(yōu)化管理相關(guān)的程序，至少包括：審核，管理評(píng)審，文件控制，質(zhì)量手冊(cè)，過(guò)程監(jiān)控，角色定義，培訓(xùn)，NP軟件確認(rèn)，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(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(wèn)題；
5. Organize and lead external audit, including: FDA, CFDA, MDSA audit, NB audit,etc.
組織并領(lǐng)導(dǎo)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(dú)立監(jiān)管員負(fù)責(zé)產(chǎn)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(xùn)內(nèi)部員工，使他們獲得良好的表現(xiàn)；
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(duì)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(guò)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. 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(zhì)量體系相關(guān)法規(guī)和標(biāo)準(zhǔn)的知識(shí)，并且具備將之導(dǎo)入質(zhì)量體系的經(jīng)驗(yàn)，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(zhì)量方法和統(tǒng)計(jì)（例如：SPC、MSA、APQP等）應(yīng)用經(jīng)驗(yàn)；
3. English ：smoothly communicate in listening, oral, write.
流利的英語(yǔ)聽(tīng)說(shuō)讀寫能力