职位描述
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.
需要坚守质量底线,通过丰富的指导和影响力来确保生产输出的高质量,常常需要克服由有限的资源和个人以及部门责任边界所带来的挑战,并且需要提出建设性意见的能力;
2. Timely track global QMS related regulation, analysis and planning of implementation and lead implementation.
及时跟踪全球各国质量体系相关法规, 分析并制定执行计划并领导导入计划的执行;
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、维护和优化管理相关的程序,至少包括:审核,管理评审,文件控制,质量手册,过程监控,角色定义,培训,NP软件确认,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.
依据质量方法(例如:8D)持续推动项目进行,协调解决质量问题;
5. Organize and lead external audit, including: FDA, CFDA, MDSA audit, NB audit,etc.
组织并领导外部审核,包括 FDA, CFDA, MDSA audit, NB audit等;
6. Responsible for product deviation and NC control as independent controller.
作为独立监管员负责产品偏差和不合格品的管理;
7. Training of internal colleagues with the target to get a solid performance
培训内部员工,使他们获得良好的表现;
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. 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.
具备丰富的质量体系相关法规和标准的知识,并且具备将之导入质量体系的经验,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.
具备丰富的质量方法和统计(例如:SPC、MSA、APQP等)应用经验;
3. English :smoothly communicate in listening, oral, write.
流利的英语听说读写能力