Commercial Quality Specialist
- Shanghai
- Permanent
- Full-time
- Perform and coordinate the complaint handling and investigations, both locally and in cooperation with AMO foreign manufacturing sites;
- Responsible for complaint handling/ AE reporting / PRER
- Handle the regional non-conformance cases as required
- Draft and update the quality procedures and perform the quality training per NMPA medical device business regulation.
- Set up the regional QMS based on JJSV division quality project;
- Manage the recall/field corrective action when required.
- Work with RA to prepare the artwork of Chinese labeling for products.
- Responsible for training and quality culture development
- Document coordinator (Agile System)
- Facilitate to execute internal audit and external audit when required.
- Lead to do NC/CAPA in responsible area
- Responsible for building and maintaining procedure of responsible process per applicable regulation & J&J requirements
- Other system supporting, such as REF distributor qualification,Supplier management, Change control management, UDI management
- Complete other tasks assigned by the manager