质量工程师

1. Participate in management review and report related work.

参与公司管理评审报告相关工作；

2. Involved in the supplier quality system audit plan, implementation, tracking, and close and related CAPA tracking.

参与相关供应商质量体系审核的计划、实施、跟踪及关闭及有关CAPA的跟踪；

3. Review inspection data, lead the investigation and report of non-conformance data.

审核检验数据，主导不合格数据的调查，报告；

4. Proactively raise improvement suggestion and drive continuous improvement based on product testing/monitor data analysis.

根据产品测试/监控数据分析，主动提出改进建议并推动持续改进;

5. Lead incoming material quality investigation and make continuous improvement.

主导进料质量问题调查和持续改进；

6. Lead quality improvement project, and support/facilitate projects including but not limited to new products introduction, CTW, sustaining etc.

主导质量改进项目，并支持/促进项目，包括但不限于新产品的引进，CTW，sustaining等项目;

7. Lead QNs and product customer complaint investigation and improvement.

主导质量异常及产品投诉的调查及改进；

8. Establish or accept transfer the measurement method for raw material inspection, in-process inspection and outgoing inspection.

建立原材料，过程检验和出货检验的测试方法；

9. Ensure all inspection tasks can be completed accurately and timely. Training inspectors and ensure online inspection efficiency and effectiveness continue improvement.

确保各项检验任务准确及时完成，培训检验员并保证在线检验效率及有效性持续改善；

10. Act as a key member of Cell team, ensure all actions meet GMP and product quality requirement, assist Cell team to do process optimization. Provide supporting for product risk management.

作为Cell团队的主要成员，确保所有的行动满足GMP和产品质量要求，协助Cell团队实施工艺流程优化，对产品的风险管理提供支持；

11. Responsible review for project validation report, ensures the content meets all applicable quality system requirements and product requirements.

负责项目验证报告的评审，确保内容符合所有适用的质量体系要求和产品要求；

12. Batch process record and data review, ensure BPR meet GMP requirement and product release on time.

批记录及数据审核，确保批记录满足GMP的要求并确保产品按时释放；

13. Promote quality culture, lead and report global quality initiative, include but not limit BBQ，GMP assessment, quality week etc.

负责质量文化的推广及总部的各项质量活动并定期汇报，包括但不限于BBQ，GMP评估，质量周等

14. QA department SAP/ECC system maintenance.

质量部门SAP/ECC系统的维护；

15. Coordinate and lead quality improvement projects.

协调、主导质量改善项目的推进；

16. Coordinate and lead Quality system& culture improvement

协调、主导质量体系和文化的改善；

17. Complete other related work.

完成交付的其他相关工作；