Our client was founded with headquartered in Hong Kong more than 20 years ago. At present, they have four production bases which are located in Anhui Province ,Shandong Province China and Yangon in Myanmar. Besides, two sterilization stations’based in Hefei Anhui China and Myanmar.The range of their business includes surgical gowns and surgical drapes&packs, protective apparels for medical as well as industrial applications,medical double-coated adhesive tape ,PE film , laminating material and other medical raw materials. Currently, the company has nearly 4,000 employees, and the Export Business Division is the largest business division, with fast-moving of the business expansion， they are looking for
Job Post: Quality Compliance Director 质量合规总监
Report to; Director of Quality Development Center
Job location: Hefei City
Key responsibilities:
岗位关键职责:
* Responsible for the construction and management of product and system compliance team
负责产品及体系合规团队的建设及管理
* Responsible for coordinating the improvement and integration of the quality management system of each factory
负责统筹各工厂质量管理体系的提升及整合
* According to new business requirements and group strategic planning, responsible for the overall planning of product and system certification, such as MDR, laboratory management system, social responsibility, environmental management, etc
根据新业务需求及集团战略规划，负责统筹产品及体系认证，如MDR、实验室管理体系、社会责任、环境管理等
* Responsible for the update and expansion of existing product certification
负责统筹现有产品认证的更新及扩证
* Responsible for the overall planning of the update, expansion and internal and external audit of the existing system certification
负责统筹现有体系认证的更新、扩证及内外审
* Responsible for the establishment, implementation and maintenance of RA processes, such as label audit, UDI management, etc
负责RA各流程的建立、执行和维护，如标签审核、UDI管理等
* Responsible for establishing publicity and training mechanism of product and system compliance
负责建立产品及体系合规的宣贯和培训机制
Key work and goals in recent 1-3 years:
近1-3年重点工作与关键目标：
* Formulated and implemented short-term and long-term product and system compliance plans of the Group according to the group’s general planning
按照集团传略规划，制定和实施集团短期和中长期产品及体系合规计划
* Complete new product and system certification on time to ensure compliance of existing products and systems
按时完成新产品及体系认证，确保现有产品及体系的合规性
* Continuously cultivate team members of the department to improve the comprehensive ability of the team
持续培养部门团队成员以提升团队综合能力岗位关键职责:
Qualification
职位要求：
* 7 years or above medical device industry quality system management and registration experience, 3 years or above team management experience
7年及以上医疗器械行业质量体系管理及注册工作经验，3年及以上团队管理经验
* Internal and external audit experience of ISO13485, QSR and other quality management systems
有ISO13485、QSR等质量管理体系内外审经验
* Experience in CE, FDA registration and certification, MDR experience is preferred
有CE、FDA等注册和认证经验，有MDR经验者优先
* Familiar with PPE regulations and standards in Europe, America and China
熟悉欧美及中国医疗器械PPE产品相关法规及标准
* Familiar with ISO quality, environment and safety standards
熟悉ISO质量、环境、安全标准
* Experience in quality management system establishment, operation and maintenance of large groups
有大型集团质量管理体系建立及运维经验
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