岗位职责：
- 致力于大中华区所有实体的ISO13485及QMS的体系的部署、监督运行，以及依据GSP要求对医疗器械的经营进行日常质量管理工作。
Focus on the ISO13485 deployment among the GC entities and monitoring its effectiveness of the implementation. Be responsible for the quality management of the medical devices according to the GSP requirement.
-协调开展区域ISO13485的部署工作，以及年度内审、外部质量审核活动。

Coordinate the ISO13485 deployment in the GC region, conduct the annual internal audit to monitor the effectiveness of the QMS implementation. Attend the cross audit in other regions outside GC.
-负责区域各子公司质量体系的培训工作，提高员工的质量意识。

Be responsible for the quality system training work to the entities in GC, improve the quality awareness to the employees.
- 作为医疗器械经营质量负责人，依据中国医疗器械相关规定负责质量工作的部署，监督维护及改进。

As the person in charge of the quality of medical device business, responsible for the deployment of quality work, supervision and maintenance and improvement according to China's medical device related regulations.
-负责与医疗器械监管机构的沟通与接受审核并跟进不符合项的整改。
Responsible for communicating with medical device authority, and accompanying the audits and following up on non-conformities.
-跟踪、了解并研究国内外医疗器械产品的法律法规。
Tracking, understanding and researching domestic and international medical device product regulations.


任职资格：
-3年以上医疗器械生产或经营的质量管理体系工作；
3+ years of quality management system work in the medical device manufacturing or sales
-具有质量管理经验，对ISO13485有深刻理解
Experience in quality management with a strong understanding of ISO13485；
-熟悉医疗器械生产/经营质量管理规范；
Familiar with Chinese GMP/GSP to the Medical device；
-有较强文字编辑能力，能独立完成各类体系文件编制；
Strong editing skills, able to independently complete the preparation of various types of system documents；
-熟悉并清楚了解相关的法律法规以及各项条款与标准。
Familiarize with the relevant laws and regulations as well as the terms and standards.


-具备良好的英语听说读写技能.中文是基本要求；
With good oral and written English skill, Chinese is a must；
-ISO 13485内审员证书者优先。
With ISO 13485 internal auditor certification is preferred.



-行业/产品相关专业本科以上学历（理工科专业）。

Bachelor's degree or higher in industry/product related field (science or engineering).