1. Quality planning, validation and control for new project 新项目的技术质量策划,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,图纸和其他要求的制定和评审
3. Complete the validation 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. 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
6. Training for inspector for quality plan, inspection 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
7. 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
8. Supervising Customer complain responding, CAPA follows up. 跟踪处理客户投诉及纠正措施的追踪
9. 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
10. Take part in quality system implementation, maintenance.质量系统的执行和维护
11. 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
12. 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
13. 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。
14. Fulfill the other tasks assigned by the manager. 上级安排的其他任务
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