Description/职位描述:

章节1：岗位概述
·      Site Administrator of ADAPTIV & CDR, ADAPTIV Change Analyst
工厂ADAPTIV和CDR管理员 & ADAPTIV变更分析员
·      Take the role of SAP superuser for quality operations in SAP system
作为SAP超级用户，进行SAP系统中的质量操作
·      Site NC Coordinator & DRB Coordinator
工厂不合格协调员和DRB协调员
·      Site Record Coordinator
工厂记录协调员
章节2：职责和责任
按照适用的联邦，洲，地方法律/法规和强生公司的程序和指南：
·      As Quality SAP superuser, execute product release related operations per site procedure and relevant documentations.
作为质量部SAP超级用户，依据工厂程序和相关文件记录执行产品放行相关操作。
·      Take the role of ADAPTIV Change Analyst and responsible for reviewing Non-PPE document related changes to ensure that Change Orders are handled with compliance to the requirement of document change management in ADAPTIV.
作为ADAPTIV变更分析员负责审阅Non-PPE文档相关的变更以确保其符合ADAPTIV文档变更管理的要求。
·      Work as Site Administrator of ADAPTIV & CDR to perform accounts activation, deactivation, role and security group maintenance for all site users and other business related to J&J associates.
作为工厂ADAPTIV和CDR系统管理员对所有工厂员工和其他有关联业务的强生员工进行账户的激活、注销，用户权限和安全组的维护。
·      As DRB Coordinator, support site CAPA lead to schedule DRB meeting, invite DRB attendees, facilitate the data collection and analysis from quality sub-system owners, track the progress of DRA through collaboration with DRA owners and support to maintain DRB related documentation.
作为DRB协调员，支持工厂CAPA负责人进行DRB会议的计划安排，邀请DRB参与人员，协调质量子系统负责人进行数据收集和分析，和DRA负责人协作进行DRA的进展追踪，并支持维护DRB相关记录。
·      As site NC Coordinator, assist site NC lead to facilitate the NC process including the NC investigation, action implementation, and NC approval & Closure.
作为工厂不合格协调员，协助工厂不合格负责人以推进不合格过程包括不合格调查，行动执行以及不合格批准和关闭。
·      Work as Site Record Coordinator to support site Record Manager to manage the process of Document Control & Record Control under Ethicon Minhang Quality Management System.
作为工厂记录协调员协助工厂记录经理以管理爱惜康闵行质量管理系统下的文档控制和记录控制流程。
·      Participate in External/Internal audit related activities.
参与外部/内部审核相关活动。
·      Support in quality related improvement projects.
支持质量相关改进项目。
·      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。
·      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。
Qualifications/任职要求:
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。
·      Minimum 2 years of experience in Quality function, in Medical Devices or Pharmaceutical industry.
至少有2年在医疗器械或医药行业质量部门的经验。
章节4: 要求的知识，技能，能力，认证/许可证和附属。
·      Detailed knowledge of medical device regulatory requirement such as ISO13485 and China GMP is necessary.
具有医疗器械法规要求的具体知识，比如ISO13485 和China GMP是必要的。
·      Must be able to communicate effectively in both English and Chinese.
必须能有效地进行中英文沟通。
·      Ability to work cooperatively with coworkers.
能与同事合作的能力。
·      Ability to use Microsoft office tool.
能使用微软工具的能力。
·      Demonstrate a strong Quality and Compliance mindset.
具有强烈的质量与合规意识

其他信息

行业要求：全部行业
所属部门：Quality