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Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:Professional
All Job Posting Locations:Shanghai, China
Job Description:章节1:岗位概述
- Assist in production process risk management and process control.
- 协助生产过程风险管理和过程控制。
- Assist in administrator of the equipment system.
- 协助实验室设备系统管理员。
- Assist in quality culture activities.
- 协助质量文化活动。
- Assist in handling BOP in quality department.
- 协助处理质量部BOP。
- As LMS administrator.
- 作为LMS管理员
章节2:职责和责任
- As production process risk management and process control coordinator, assist in maintaining risk management documents, on-site IPQA, material disposition of short expiry date, test data review and analysis, provide product COC, and other related tasks.
- 作为生产过程风险管理和过程控制协调员,协助维护风险管理文件、现场IPQA、短有效期物料处置、测试数据审阅分析、出具产品符合性证明等相关工作。
- Assist lab equipment system administrator, address lab system user access review, lab system audit trail review and data backup.
- 协助实验室设备系统管理员执行实验室设备用户权限管理、审计追踪审阅和数据备份。
- As quality culture coordinator, assist in routine Great Catch cases collection, disposition and feedback, and promote site quality culture and hold quality culture activities.
- 作为质量文化协调员,协助日常Great Catch收集、处置和反馈,以及推动工厂质量文化和举办质量文化活动。
- As quality building ownership program coordinator, assist the Facility Department in handling BOP
- 作为质量部BOP协调员,协助设施部处理BOP。
- As LMS administrator, create/maintain/assign training items, provide training data/reports based on business needs, and support the execution of training activities at the Minhang site.
- 作为LMS管理员,创建/维护/分配培训课程,根据业务需求提供培训数据/报告,支持闵行工厂的培训执行工作。
- Responsible for communicating business related issues or opportunities to next management level.
- 负责将业务相关问题或机会传达给下一级管理层。
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- 负责遵循公司与健康,安全和环境相关的所有适用的实践。
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- 对于那些监督或管理员工的人员,如适用,负责确保下属遵循与健康,安全和环境实践相关的所有公司指南,以及所有需要的资源都是可用的,且状况良好。
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- 负责确保个人和公司遵守联邦、州、地方和公司的所有法规、政策和程序。
- Performs other duties assigned as needed
- 执行其他必要的职责。
章节 3:经验和教育
- University/Bachelor's Degree or Equivalent.
- 大学本科学历或同等学历。
- 1-2 years of experience in Quality function, in Medical Devices or Pharmaceutical industry.
- 1-2年在医疗器械或医药行业质量部门的经验。
- Better to have knowledge of medical device regulatory requirement such as ISO13485 and China GMP is necessary, and some professional skills such as FMEA, Minitab, Power BI.
- 最好具有医疗器械法规要求的具体知识,比如ISO13485 和China GMP,以及专业技能,比如FMEA, Minitab, Power BI。
Required Skills: Preferred Skills:Analytical Reasoning, Business Behavior, Compliance Management, Detail-Oriented, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Assurance (QA), Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards
