质量体系工程师

1） 负责建立和维护公司质量体系
2） 负责外部审核前的沟通准备和审核现场的协调
3） 负责推动审核问题的整改与跟踪，确保审核问题及时有效关闭
4） 负责内部审核和产品GMP自查，日常巡检等工作，对发现的问题进行推进和跟踪
5） 负责质量体系文件的梳理和优化及监督执行
6） 负责公司管理评审，包括管理评审输入输出及措施的跟踪
7） 负责跟踪行业中体系法规标准的更新及转化和推行

任职资格:
1） 本科及以上学历，医学，理工科相关专业
2） 具有医疗器械质量体系相关工作经验3年以上
3） 熟悉国内外质量体系法规标准，包括ISO13485，医疗器械生产质量管理规范，无菌医疗器械生产质量管理规范等
4） 有ISO13485内审员证书优先
5） 工作细致，责任心强，有较好的逻辑分析能力和团队合作精神
6） 较好的沟通和表达能力

Job responsibility
1. Responsible for setting up and maintaining the company quality system

2. Responsible for the preparation of audit communication and coordination of aduit site

3. Responsible for promoting the rectification and tracking of audit issues to ensure the aduit’s issue can be closed effectively

4. Responsible for internal aduit,self-inspection and routine inspection in order to be able to advance and track the problems found
5. Responsible for carding, optimize and oversee the implementation of quality system’s documents.
6. Responsible for company management review, includes management review input and output as well as measures tracking
7. Responsible for following up the update, transformation and implementation of regulations and standards


任职资格Job requirements

1. Achelor degree or above, major in medicine, science or engineering is preferred

2. At 3 years working experience in medical device quality system

3. Familiar with domestic and international quality system regulations and standards, includes ISO13485, Specification for quality management of medical device production,Specification for quality management of sterile medical devices

4. Internal auditor qualification certificate of ISO13485 is preferred

5. Strong sense of responsibility, work carefully and meticulously,good logical analysis ability and team-work spirit

6. Good communication skills and ability
7. Proficient in verbal and written English and communication skills in written by English