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.
依据质量方法（例如：8D）持续推动项目进行，协调解决质量问题；"
2. Training and guidance of internal colleagues and Suppliers with the target to get a solid performance
培训指导内部员工、供应商，使他们获得良好的表现；"
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
及时跟踪全球生产和供应商相关法规（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)， 分析并制定执行计划并领导导入计划的执行；
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.
通过对供应链团队的指导，培训，审核，主评审，沟通，影响和 其它需要之方法， 以实现SCM高质量的产品输出（包括文档和记录），同时确保产品对法规、标准和客户要求的满足, 并作为独立监管员签署并发布放行产品和生产过程的变更。
5. Planning,prepare and reply for SCM and supplier related issues during external audit, including: FDA, CFDA, MDSA audit, NB audit,etc.
外部审核时，负责SCM和供应商相关任务的计划、准备和回答，审核包括 FDA, CFDA, MDSA audit, NB audit,etc.
6. Responsible for product deviation and NC control as indepent controller
作为独立监管员负责产品偏差和不合格品的管理；"
7. Production final inspection accurance for product release
产品终检放行。"
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.
权限：对质量事务提供质量指导。介入，统筹处理并报告不符合法规的事件。向中止产品发货或服务的决策过程进行报告。有权获得所有质量相关数据。
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
