招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
1. Creation and development of technical documentation as well as the management and control of a corporate Quality documentation system, including the documents, records and associated processes.
2. Review and distribute the new/revised document as per document change request.
3. Establishes and maintains a central repository, including history files, for all controlled Quality & Regulatory documents and records.
4. Perform various duties essential to the implementation and maintenance of a regulated documentation system, including coordinating efforts for the control of new and updated Quality System procedures for ISO/QSR.
5. Ensure the consistency and quality system of Medical Device product, process, and policy documentation.
6. Clean room monitoring monthly and data analysis.
7. Follow up the internal audit and external audit findings to ensure the closure timely.
8. In-charge of review the DHR and batch record.
9. Support QA Dept. for the daily grind, including office supply requisition and checking attendance each month by system.
10. Review of Sterilization report and certificate; Review COC for outgoing goods.
11. Supervise and coordinate with Micro lab technician for Micro lab daily operations.
12. Perform orientation training for new employee.
13. Involve in product registration in China.
14. Finish other task which supervisor assign in time.
1. At least 3 years ISO 13485 QMS and CFDA regulation of medical device experience.
2. Candidate with Medical System and Class II Medical devices registration experiences are prior.
3.Familiar with ISO13485/China standard®ulation for medical device.
求职提醒：求职过程请勿缴纳费用，谨防诈骗！若信息不实请举报。
