Sr. Quality System Engineer 高级质量体系工程师

协调集团内审和外部质量管理体系审核，包括ISO13485, MDSAP, FDA QSR820, 中国药监审核和其他审核比如Costco GMP审核等，跟踪不符合项的改进预防措施。

85 Lead implementation of internal quality system audit and the follow up corrective and preventive activities.

主导实施质量体系内审及后续的改进预防措施的追踪。

85 Daily maintain and improve the quality system, monitor quality system implementation of each department and Cooperate with Global functions to ensure effective communication and implementation of Global QMS requirements related to local site.

日常维护和完善质量体系. 监督各部门的质量体系的正确执行。与集团部门协作确保跟本地相关的质量管理体系要求沟通且执行到位。

85 Collect, maintain and understand related legal requirements of company QMS, ensure the legal compliance of company QMS.

收集、维护并理解与公司QMS相关的法律法规要求，确保公司QMS的法规符合性

85 Assist relative department for building the quality assurance process/system for the new or change process.

协助相关部门针对新建或变更过程建立质量保证过程或系统.

85 Train newcomers occasionally about company level requirements of quality management system

负责公司级别质量管理体系要求的培训和教育。

85 Company KPI data collection, management and reporting

公司关键绩效数据收集、管理和汇报

85 Continuously contribute, develop and implement ideas that improve performance.

持续改进，不断提高工作绩效。

85 Other tasks assigned by the superior.

85 其他上级交办事项。

任职要求：

1.Bachelor or above in mechanical/electronic field preferred

本科或以上 机械或电子专业优先

2.Above 5 years relevant working experience,

5年以上相关工作经验;

3.Good knowledge of ISO9001 and ISO13485 and MDSAP, and with the capability of planning QMS of medical device industry;

良好的ISO9001和ISO13485/ MDSAP质量系统知识；具备医疗器械行业QMS策划的能力

4.Familiar with FDA QSR820 quality system, and China GMP etc.

熟悉FDA QSR820和中国GMP等要求

5.Excellent English skill

优秀的英语能力

6.Good coordination and communication skill

良好的协调和沟通能力

7.High responsibility

责任心强