1. 根据公司业务要求和法律法规要求持续建立维护和优化质量体系，以确保质量体系的有效性，及时性和合规性。
Establish，maintain and optimize the QMS continuously according to business requirement, quality regulations and standards, to ensure the quality management system’s effectiveness, efficiency and compliance.
2. 定期更新SOP更新，与总部合作，组织并跟踪实施。
Regular SOP update, cooperate with Head quarter, organize and follow up the implementation.
3. 有序管理QMS培训，提高组织质量意识。
Manage QMS training orderly, improve the organization quality sense.
4. 准备并协助外部和内部审计，确保业务部门顺利通过外部审计。有效地推动和跟进调查结果，直至其结束。
Prepare and associate the external and internal audit, ensure business unit can pass the external audit smoothly. Push and follow up the findings effectively till their closure.
5. 监控质量管理体系运行状态，定期生成质量管理体系状态报告。
Monitor quality management system operation status and generate QMS status report in regular interval.
6. 组织CAPA会议，推动和跟进CAPA直至其结束。
Organize CAPA meeting, push and follow-up CAPAs till their closure.
7. 负责GMP自检，并向NMPA提供年度报告。
Be responsible for GMP self-check and provide the annual report to NMPA.
8. 支持后市场（上市后监控）、医疗器械注册工作（ 注册/认证资料编写；与检测所沟通检测进度, 注册/认证证书的变更、延续，及各类法规相关资料的办理）。
Support PMS, medical device registration (preparation of registration/certification files; communicate with testing lab about testing progress, registration/certification change, extension, and all kinds of regulations related information processing).
9. 积极完成交付的其他质量相关的工作。
Actively complete other quality related work assigned.
REQUIREMENTS：
61 本科以上学历
Bachelor degree is required
61 至少4-5年的医疗器械质量工作经验
At least 4-5 years of medical device working experience in quality.
61 具有质量管理体系维护和优化、内部和外部审核、CAPA/NC处理的经验
Experience with quality management system maintained and optimization, internal and external audit, CAPA/NC handling
61 有ISO13485内审证，此外，***有MDSAP/QSR820/MDR培训认证。
Certification on ISO13485, in addition nice to have MDSAP/QSR820/MDR training certification.
61 熟悉有源医疗器械标准和法规要求，如IEC60601-1/GB9706.1，IEC60601-1-2/YY0505等通用标准。
Familiar with active medical device standards and regulatory requirements, such as IEC60601-1/GB9706.1, IEC60601-1-2/YY0505 and other general standards.
61 熟悉国内注册相关法规要求，参与过有源医疗器械产品的注册项目优先
Familiar with the relevant regulations and requirements of domestic registration, participating in the registration project of active medical device products is preferred.
61 具有良好的协调和沟通能力，具有独立思考和分析解决问题的能力；
Good coordination and communication skills, independent thinking, analysis and problem-solving skills.
61 具备团队协作精神及工作责任感。
Team spirit and sense of responsibility.