This position will be leading and driving following activities:
To work with overseas manufacture sites on establishing the process of complaint handling and quality improvement; To work with local commercial team on complaint initial investigation and improvement closely Be responsible for complaint handled in a time manner; Monitor the actions from complaint investigation implementation progress and give feedback in timely manner; Figure out complaint negative trends and work with local commercial team, supply chain, Technical Service and overseas manufacture sites closely to settle the issues in advance; Escalate the potential field corrective actions on nonconformance of the products found and implement field corrective action; Follow up the CAPAs triggered by customer complaints; Conduct the training to teams and members involved in the process of complaint handling continuously to improve the quality sense of local commercial team, especially complaint reporting related; Review and optimize the process of complaint handling and work out the improvement plan and implement it;
Adverse Event Handling and Management
Initial judgment on the reportable AE; Organize the cross-functional teams to work out proper report; Ensure all adverse events including local and oversea AE reporting are handled in timely manner and comply with requirement of regulation; Perform the communication with the Competent Authority.
Recall & FCA management
1. Work out the communication material for recall;
2. Lead the cross-functional team to handle all the recalls in timely manner
3. Perform the communication with the Competent Authority and work out the report by the requirement of regulation.
Other tasks assigned by line manager.