1. 组织公司质量管理体系的建立、运行、维护，并通过第三方认证；

2. Establish, maintain of the company's quality management system, and pass the third-party certification;负责组织公司质量管理体系的内部审核、客户审核、第三方认证审核、药监局产品注册审核和生产许可证认证审核；

Responsible for organizing the internal audit, customer audit, third-party certification audit, product registration audit of NMPA and production license certification audit;

协助管理者代表策划管理评审会议，负责编制管理评审计划、管理评审会议的输入和输出报1. 告；

Assist the management representative to plan the management review meeting, and be responsible for initiating management review plan and manage the input and output reports of the management review meeting;

2. 组织公司质量检验标准、检验流程的制定，并监督其运行；

Organize the formulation of the company's quality inspection standards and inspection procedure, and monitoring operation;

3. 组织质量管理部管理制度、工作流程的编制、评审和监督运行；

Organize the preparation, review and supervision of the quality management system and workflow of the quality management department.

4. 负责组织公司质量事故的调查处理；

Responsible for organizing the investigation and handling of the company's quality accidents.

5. 审核质量报告，并作出分析与改善对策；Review the quality report, and make analysis and improvement countermeasures;

6. 负责组织客诉问题的处理、改善和监督处理方案和改善方案的执行；

Responsible for organizing the handling of customer complaints, improving and supervising the implementation of the disposition plan and the improvement plan;

7. 负责本部门工作计划的制定、工作总结和分析；

Responsible for initiating work plan of the quality department, summarize it and analyze it;

8. 负责组织实施本部门的质量记录、数据的归档工作；

Responsible for organizing and implementing the archiving of quality records and data of the department;

9. 负责下属工作计划方案、报告报表、总结、申请等的审核和工作安排、指导、督促、检查；

Responsible for management subordinates, guidance, supervision and inspection of work plans , reports, summaries, applications, etc.

10. 负责本部门人力资源的规划、评估及任用；

Responsible for developing department, including evaluation, planning, recruiting, appointment.

11. 负责部门间、部门内工作沟通、协调与配合；

Responsible for internal and external communication, coordination and cooperation.