Commercial QA Supervisor

 QMS Process maintenance & improvement

质量体系流程维护和优化

 Drive product quality improvement and cost of quality improvement

推动产品质量改进和质量成本优化

 Distributor management & audit

经销商管理和审核

 Document control and quality training management

文件控制及质量培训管理

 Advertising and promotional material review and submission

广告材料审核和递交

 Medical device purchaser management & Product first approval review

医疗器械购货者管理和产品首营审核

 Self-inspection report and NMPA traceability system data maintenance

自查报告和药监追溯系统数据维护

 Sales operation & E-commerce quality support

销售运营和电商质量支持

 Nonconforming product disposition and complaint handling

不合格产品处置和投诉处理

 Recall and Periodic Risk Evaluation Report (PRER) management

召回和定期风险评价报告（PRER）管理

 Labeling and instructions for use data maintenance

标签及说明书数据维护

 Any agreed-to works by supervisor

主管安排的其它工作

任职资格:

Functional Knowledge 职能知识：

 Requires conceptual and practical expertise in own discipline and basic knowledge of related disciplines

要求掌握自己学科中的概念和实践专业知识以及相关学科的基本知识

Business Expertise业务专业知识:

 Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

拥有最佳实践知识并知晓自己的领域与他人结合的方式；了解竞争以及让其在市场中脱颖而出的因素

Leadership领导力:

 Acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements

作为资历尚浅同事的资源；能够领导带有可管理风险和资源要求的小型项目

Problem Solving解决问题:

 Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information

解决复杂问题；采用关于现有解决方案的新视角；基于多个来源的信息分析作出判断

Impact影响:

 Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies

在自己团队和其他相关团队中影响众多客户、经营活动、项目或服务活动；根据广泛的指导原则和政策开展工作

Interpersonal Skills人际交往技巧:

 Explains difficult or sensitive information; works to build consensus

诠释困难或敏感信息；开展工作以达成共识

Education & Experience学历与经验:

 Bachelor’s degree in field with 10+ years exp. OR

本科以上学历，10年以上工作经验；

 At least 5 years QMS experience，with deep understanding for medical device related regulations

5年以上质量管理体系工作经验, 对医疗器械相关法规有深度理解；

 Familiar with ISO13485 or ISO9001

熟悉ISO13485 或 ISO9001

 Have NMPA inspection handling experience

有NMPA应审经验

 Proficient in English as working language

英语作为工作语言，听说写精通

 Life science relevant major preferred

生命科学相关专业优先