Job Description:

1. Assure the effective implementation, integration and execution of the China LoopLab Quality Management System across operations and contract manufacturers;

2. Provides direction and infrastructure to assure timely' precise and effective discovery of potential non-conforming product with resources internally and with the contract manufacturer to respond to incidents;

3. Responsible for assuring, assessing and verifying the execution of all conformance activities;

4. Assure implementation and execution of process/program infrastructure for reporting, change management and sample/qualification request management with internal organisations such as Regulatory Affairs;

5. Product Design & Development, and Procurement. Ensure timely resolution of supplier failure, corrective actions and preventive actions;

6. Manage the quality assurance china operations organisation;

7. Proactively identify areas of compliance vulnerability and risk and develop programs to mitigate such risk;

8. Conduct on-going analysis and interpretation of central and provincial applicable laws and regulations and update internal compliance policies and procedures accordingly;

9. Conduct quarterly internal audit for CMO;

10. Coordination, oversight and accountability for the management of audits conducted by 3rd party at the CMOs and the China office;

Job Qualifications:

• Bachelor’s Degree, in an appropriate technical field such as Pharmaceutical, Chemical, Medical Technology, Biology, Engineering or any other related science is required;
• Statistical knowledge is required;
• Computer literate;
• Good verbal and written communication skills in English fluently;
• Minimum 8 years’ experience in a Medical Device or Pharmaceutical Industry is required;
• 5 years with quality management responsibility is required;
• Certification in CQA is preferred, CQE, CQM, and/or member of ASQ is desired;
• Team leader skills required for proper team and cross-functional coordination;
• Strong analytical skills

上班地址：科技园北区朗山一路6号意中利科技园1栋5楼/2栋3楼