岗位要求描述：
Responsibilities/岗位职责:
1. Quality planning, validation and control for new project
新项目的质量策划，验证和质量控制
2. Review the product Specification, drawing and special requirement for new project. 新项目产品规范，图纸和其他要求的评审
3. Draft the validation protocol together with the project team members
与项目团队一起完成验证计划
4. Work out the related document for Medical project, as DMR, DHR, FMEA, C/P etc. 医疗项目的其他文件起草，如DMR，DHR，FMEA，C/P 等
5. Summarize the validation report together with the project team members.
与项目团队一起完成验证报告
6. Design quality plan, inspection instruction, and test method for new project
定义新项目的检验计划，检验指导书和测试方法
7. Training for inspector for quality plan, inspection instruction and test method. 对检验员进行检验计划，检验指导书和测试方法的培训
8. Coordinate with project team for the engineer change ｆｒｏｍ　both internal and external .参与项目团队内部或外部的工程变更
9. Customer complain responding, CAPA follows up.
处理客户投诉及纠正措施的追踪
10. Response for stopping the line as any serious issue in process and nonconformity products controlling. 过程中出现任何质量负责中断生产和不合格品的控制
11. Take part in quality system implementation, maintenance.
质量系统的执行和维护
12. Cooperate with RA team for the product registration for domestic project
协助法务部门完成国内销售的产品注册
13. Collect process quality data and quality trend analysis.
收集过程质量数据并完成趋势分析和改进
14. Coordinate and supporting to audit ｆｒｏｍ　FDA/NMPA/the 3rd-Parties/customers..协调并支持药监局、第三方、客户的审核。
15. Fulfill the other tasks assigned by the manager. 上级安排的其他任务

任职要求：
1. Bachelor degree or above with Good English skill both in written and oral.
本科或以上学历，良好的英语读写能力
2. At least 3 years relevant working experience in international company, any Pharmacy or medical device manufacturing experience is preferred.
3年以上的外企相关工作经验，有药品或医疗生产企业工作经验优先， 消毒类产品经验优先。
3. Be familiar with process management and new project quality management.sanitizing experience is preferred.
熟悉过程管理和新项目的质量管理
4. Be familiar with GMP or ISO13485 and relative quality tools.
熟悉GMP 或ISO13485和其他质量法规
5. Good communication and team work skill. 良好的沟通能力和团队合作能力
6. With responsible, and careful personality. 细心，责任心强

*苏州相城区，配合公司下属其他分公司出差。薪资面议