【请注意工作地点为：苏州】

负责公司质量管理体系建设、维护和管理工作；并对质量管理制度的执行情况进行检查、纠正和持续改进
Responsible for the Quality Management System Construction, maintenance, management. And monitor, correct and continuous improve the implementation of Quality Management System
受控文件的定期回顾
Take charge for periodic review of controlled documentation
负责质量管理体系、相关程序文件、法规要求，以及操作系统的培训
Responsible for the training of Quality Management System, related procedure & regulatory demand, and operating system
公司ISO 13485证书的有效性维持
ISO 13485 certificate valid maintenance
负责纠正预防措施（CAPA）、以及NC的跟踪和管理
In charge of CAPA and NC follow up and management
策划和实施公司年度管理评审
Organize and implement annual management review
组织和实施苏州工厂的定期内部审核
Organize and implement regular audit in Suzhou Plant
负责来自集团公司的审核；以及审计机构和客户的外部审核
In charge of audit come from Headquarter, thirty-party and customer
与总部公司保持密切、友好的沟通；确保质量体系及程序文件的适用性、符合性
Keep close and good communication with headquarter company. Deal well with the applicability and compliance in Quality System and Procedure
完成上级领导交办的其它工作
Finish the other jobs assigned by manager
任职要求：
本科或以上学历Bachelor degree or above
1. 从事医疗器械质量体系管理8年以上工作经验；熟悉ISO 13485 / FDA 21CFR 820 / MDD 93/42/EEC等法规要求 With more than 5years QMS in medical device. Familiar with ISO 13485, FDA 21CFR 820 / MDD 93/42/EEC regulatory requirement, etc.
2.必须具备医疗器械工厂关于FDA QSR 820（21 CFR PART 820）的审核经验 Must have the audit experience of FDA QSR 820（21 CFR PART 820）in medical device factory.
3.具备医疗器械工厂GMP认证经验 Have the experience of GMP certification regarding medical device factory.
4. 必须对ISO 13485非常了解Must be well understand about ISO 13485
5. 具备ISO 13485内审员证书Have the internal auditor certificate of ISO 13485
6. 必须具备独立接待来自审计机构和客户等外部审核的能力 Must have the ability of independent reception external audit which come from audit authority and client, etc.
7. 抗压能力强。正直诚信，仔细，责任心、执行力、学习能力强。Strong ability to work under pressure. Honest, cautious, and strong sense of responsibility, execution, learning capability.
8. 必须具备独立完成工作的能力、有主见。Must have the ability to work independently, and he or she should be strong-minded people.
9. 具备在集团公司内跨公司、跨部门较强沟通协作的能力 Strong ability to communicate and coordinate with cross function departments in group company.
10. 熟悉日常办公软件的使用，Word，Excel，PPT技巧熟练 Familiar with the use of daily office software, skilled at word, excel and PPT
11. 英语听说读写能力良好。With good English spoken and writing ability.

The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.  Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.      Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.  Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.  The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

http://www.sol-m.com