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• 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