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**Job Function: **
Non-Standard
**Job Sub Function: **
Non-Employee
Job Category:
Non-Standard
All Job Posting Locations:
Shanghai, China
Job Description:
- • Perform quality support duties including maintenance of Document management and training management.
- • Build QMS quality system cased on regulatory and J&J requirements; PMS supervision and handling (AE/complaints/field action).
- • Provides support for special quality projects. Ensures and maintains a state of inspection readiness.
- • Performs in various quality functional areas and maintain expertise. Adheres to environmental policy, procedures, and supports department environmental objectives.
- • 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
**Required Skills: **
Preferred Skills: