1.Responsible for the collection, reporting, investigation, analysis, evaluation, control and follow-up of medical device complaints/adverse events for LivaNova's equipment; responsible for the preparation of adverse event related reports for LivaNova's equipment; communication with the authorities;
2.Responsible for customer letter generation/issuance and credit note communication for both disposibles and equipment;
3.Manage local labeling activities for LivaNova's equipment, incl. review and approval of label template/label inspection records/local labeling work order/inspection report after local labeling, final product release and other local labeling related activities and communication with the global team;
4.Responsible for review of the product returns for LivaNova's equipment;
5.Correctly enter the "Medical Device Management Enterprise Information Traceability Declaration System" to ensure product traceability;
6.Responsible for medical device recalls for LivaNova's equipment;

7.Responsible for 3PL deviation handling for disposibles and equipment;
8.Ensure that corporate and local procedures are followed. Drive the PMS related procedure revision to comply with NMPA medical device regulation;
9.Participant in internal and external audit;
10.Support on APAC PMS if required;
11.Other tasks assigned by the line manager.
Language skills: Fluent Chinese and English in oral and written.
Computer skills: familiar with MS software, knowledge of Excel for the data analysis, power point for the monthly presentation.
Other special requirement: Strong in skills of communication with different parties, independent problem-solving ability etc.
Education
University graduate with background in Medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, computer science, law or management.


Experience
Position experiences: should have above 3 years QA experience in commercial or manufacturing company, China post-market surveillance is a plus. Experience of working in Foreign invested company/Multi-national company is preferred.
Good understanding of GSP or GMP, and other PMS related regulations with very good risk sense and risk management skills.
Computer skills: familiar with MS software, knowledge of Excel for data analysis, power point for requested presentation.

其他信息
语言要求：英语
行业要求：全部行业
所属部门：QA