BD (Becton, Dickinson and Company) Customer Complaint Specialist in Kuala Lumpur, Malaysia
Job Description Summary
Reporting to the Senior Manager, Customer Quality, Greater Asia, this position is responsible for managing the activities and procedures associated with complaints in the Asia Pacific region. He/she is accountable for setting own work direction and completing work tasks which include the following- effective and timely processing of customer complaints including maintenance of complaint files, liaison with Business/ Customers/ Manufacturers, responses to customers and Complaint Quality reports; perform review of Adverse Events (injury complaints) for reportability to regulatory authorities.
Review all Customer complaints about validity and assures complaints are processed in compliance with Company policies and procedures.
Responsible for all complaints originating in the region.
Implement and follow procedures to ensure timely and accurate receipt, logging, analysis, and response to customer complaints. These activities include:
Enter complaint information into the electronic complaint handling system. Generate acknowledgment emails. Complete Regional Decision Tree. Sample follow up/management. Assign complaint to Complaint Investigation Site (CIS) and/or Designated Complaint Handling Unit (DCHU) Monitor and update status. Generate customer response letters and coordinate translation (as needed). Closure of complaint in the system Complaint metrics tracking Complaint trend analysis and reports Notify and engage the manufacturing sites for investigation
Maintain systems to monitor and facilitate timely investigations and close out of open complaints. Ensure systems at workflow preclude lengthy unanswered complaints. Responsible for the management of the complaint handling process for the AP region, activities include:
Prepare and analyze complaint trends for the country/region. Monitor and communicate significant quality trends and identifying adequate corrective actions. Provide internal awareness of noted trends and quality issues via periodic and ad hoc reports.
Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
Provide training to personnel involved in complaint investigation and complaint systems (such as Trackwise, Salesforce, Service-Max, etc) users, as a directive by the Supervisor.
Perform review of Adverse Events (injury complaints) for reportability to regulatory authorities for multiple countries according to BD procedures.
Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering the course of action when and where necessary.
Remain current in any upgrades to complaint handling systems.
Ensure that the Service Level Agreement (SLA) metrics are met.
Comply with all ISO 13485 requirements and BD policies.
Ensure a safe, healthy and environmentally friendly workplace by observing Company’s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement, and reduction of resource materials.
Executes any tasks and/or projects as assigned by the RCC Team Lead and/or Quality Manager, Greater Asia.
Primary Work Location
MYS Kuala Lumpur - Jalan Kerinchi
MY1 Standard (Malaysia)
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.