Responsible for the management of the complaint handling team and process for receiving/investigation on returned complaint product from all regions.
Establish and monitors complaint metrics and drives process improvements to streamline complaint handling based on performance trends.
Responsible for compiling and generating complaint reports/metrics on the field performance.
Responsible for the post-market surveillance process and reporting.
Responsible for issuance of investigation report or letter on alleged defective products to customer when necessary.
Lead and drive complex product failure analysis and investigation, to identify the failure modes and root cause.
Initiate and facilitate corrective or preventative actions as needed, identify issue related to manufacturing or design deficiency and drive on corrective and/or preventive actions.
Audit on completed complaint files to ensure compliance to Quality Management System and regulatory requirements
Support and participate in internal and external audits.
Manage and develop a center of excellence team that provides leadership, best manufacturing practices, research, support and/or training for manufacturing site. Identify technical and people management skill set gaps. Develop direct reports skills through development plan execution
Manages prioritization of team resources and deliverables.
Execute projects and any others related activities as directed by supervisor.