协助建立、维护和持续改进公司质量管理体系，保证质量体系有效运行。创建并维护质量体系文件以支持业务需求，并符合标准和法规要求。定期组织质量体系内部审核，以及内部审核发现项的整改跟踪，确保相关整改措施及时关闭。协助完成管理评审会议，以及管理评审措施跟踪。负责并协调外部审核的准备，执行及后续审核发现项的跟踪，确保相关整改措施及时关闭。参与法律法规的评审，协助识别适用的法律法规，必要时将法规要求转为公司内部的质量管理体系流程。负责公司质量体系流程优化和改进工作。负责质量体系相关的培训，提升公司员工的质量意识。负责工厂CAPA系统的维护，组织CAPA会议，推动和跟进CAPA直至结束，确保CAPA流程持续合规。与现场流程负责人合作，定义流程和系统改进，实现“持续改进”的价值。以高效专业的方式与各部门在各个层次上进行沟通，以满足质量体系的要求

根据要求协助所有现场质量体系项目，积极参与团队工作以实现公司质量目标。

完成上级安排的其他工作。

English

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