Main Responsibilities:

1. Support manager to maintain the quality management system for China local commercial organization to comply with China GSP regulations and Corporate Quality Management System.

2. Work closely with cross-functional team to create, maintain and continual optimize China local SOP documents to meet with GSP regulation and business needs.

3. Conduct quality surveillance and maintain information of customer license, vendor license and product in SAP system.

4. Update the changes of NMPA regulations on medical device distribution to China business team and provide support on warehouse management.

5. Maintain the GSP license to be continual effective for China business needs, including but not limited to, extend license scope, renew license and other changes for license.

6. Act as the contact person, keep closely working relationship with local NMPA authority.

7. Conduct and/or support the staff training and education on regulations and quality system.

8. Support manager to maintain ISO 13485 Quality Management System for Greater China region.

9. Other duties assigned by manager.
Experience, Knowledge and Skill:

1. Bachelor’s degree or above major in Science related.

2. At least 3 years professional experience in quality assurance in medical device industry.

3. Solid knowledge on China medical device regulations especially for GSP regulations.

4. Hands-on experiences in GSP compliance and warehouse management. ISO 13485 QMS internal audit experience is preferred.

5. Familiar with ISO13485 Quality management system, certified internal auditor for ISO13485 is preferred.

6. Proficient English skills both written and speaking.

7. Proficient skills in Microsoft office, familiar with SAP / Unity is preferred.

8. Proficient skills in cross-functional communication and coordination.

其他信息
语言要求：英语、普通话
行业要求：全部行业