工作职责：
1、组织运行、监督IATF16949、ISO9001等体系运作，对不顺畅流程与相关部门进行沟通改善；
2、优化各项体系制度文件，使之更加适用于公司发展，查核各部门文件的实施情况，督促各部门依照文件规定流程执行；
3、开展内审、外审等工作，提出改进需求及建议，并跟踪不符合项的改进，维护体系正常运作；                                                                                                                                 4、设计并实施关于体系的员工培训，提升员工体系运行能力；
5、追踪公司体系目标数据，收集，统计、分析和通报。
任职资格：
1、大专或以上学历，相关专业背景，如工程管理、质量管理等；
2、熟悉IATF16949、ISO9001等体系运行，有内外审经验；
3、有较强的文档编辑和管理能力，熟悉文件管理及现场稽核；
4、具备组织内审活动及培训能力。
福利待遇：
1、五天8小时工作制，周末双休；                                                                                                 2、五险一金，包吃包住，年终奖；                                                                                  3、带薪假期，加班补助，节日福利，生日津贴，专业培训，团建活动，其它福利

工作地点

广东省东莞市南城区石鼓工业区A栋四楼东莞市科惠工业材料有限公司

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职位概要(Job summary): 
The Regulatory Compliance Sr. Engineer is to monitor and ensure the compliance to external standards/requirements and Quasar Quality System Requirements in Quasar manufacturing site.
 工作职责(Responsibilities): 
1. Conduct routine monitoring, checking program to identify site compliance gaps and follow up gap remediation. 
2. Participate in Corporate Procedure Development & Maintenance. Join Corporate audit on other sites when required.
3. Provide Regulation Compliance supporting on critical business projects, when necessary, e.g., MAH
4. Facilitate critical external audits/inspection at site. e.g., FDA inspection, NMPA audits. 
5. Join cross sites QMS IT system coordination and maintenance.
6. Responsible for liaising with the company’s internal/external stakeholders to identify/understand the required Regulatory Compliance knowledge needed to provide the required expertise and advice.
7. Other tasks assigned by leader.

任职资格(Qualification) :
1. Bachelor or Master’s degree in science related field. 
2. Minimum of 5 years’ experiences on Medical Device or Pharmaceutical Industry Quality Regulatory Compliance related work. Knowledgeable on international standards or Health Authorities regulations requirement.
3. Good oral and written communication skills both in English and Chinese.
4. Good interpersonal and influential skills.
5. Ability to work under pressure in a dynamic environment.

工作地点

广东省东莞市东坑镇兴业路2号机器人产业园5栋

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