SPECIFIC RESPONSIBILITES：
1. Prepare and revise standard operating procedures (SOPs). 起草和修订标准操作流程
2. Handling EQMS system covering various modules such as document management, change management, audit, CAPA, etc.质量管理在线系统操作,包括文件管理，变更控制，审计管理和纠正预防措施等。
3. Prepares for and assists in conducting internal/external audits, and tracks audit findings to ensure corrective and preventative actions are taken. 准备和配合执行内审和外审，追踪审核发现项以确保纠正和预防行动的执行
4. Handles product quality complaints, tracks investigation result of quality incidents. 处理产品质量投诉，追踪质量事故调查结果
5. Cooperate with supervisor to achieve continuous improvement of quality management配合主管实现质量管理的持续改进
6. Generates, reviews, and approves documentation and reports to support clients’ products. 建立，复核，批准文件记录和报告以支持客户产品
7. Performs and tracks on employee training on procedures to ensure required training is complete timely. 执行员工培训和跟踪，并确保培训的及时完成
8. Performs on-site inspection for Chinese relabeling process.对中文贴标过程进行在线检查
9. Performs product incoming inspection including cold chain IVD product and freezer product执行产品入库验收检查,包含冷链 IVD产品和冷冻产品
10. ｅｘｅｃutes systematic hold/release process to ensure appropriate product releases. 执行系统冻结和放行流程，确保适当的产品被放行
11. Implement global document translation, mutual check and apply for document effective in the system. 总部流程文件的翻译，互检及申请系统文件生效。
12. Performs periodic facility inspections to ensure compliance with processes.执行定期仓库检查确保流程合规
13. Completes other works which are assigned by supervisor. 完成上级所分配的其它工作内容

JOB SPECIFICATIONS:

Educational level and other Technical/Professional Qualification:
Must have major in below mentioned degree program: including laboratory science, biomedical engineering, biochemistry, immunology, geｎｅｔics, pharmacy, biotechnology, clinical medicine, medical equipment college degree or above, and should have more than 3 years of work experience in medical device quality management.

具有检验学、生物医学工程、生物化学、免疫学、基因学、药学、生物技术、临床医学或 医疗器械专业任何一种大专以上学历或者中级以上专业技术职称

同时应当具有3年以上医疗器械质量管理工作经历。

Traits
Good English (with CET-4 certificate) and computer skill良好的英语读写水平(CET-4)和计算机技术
Good communication skill良好的沟通技术

上班地址：-上海-上海市浦东新区外高桥保税区日阪路301号UPS