Job Description

Summary Who We Are BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who poss Summary Who We Are BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. 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. Purpose : Reporting to the Asia Pacific Regional Complaints Centre (APRCC), Team Lead. 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. Key Responsibilities Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance. 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 Support the review of service complaint cases and work orders for countries in the Asia Pacific Region if required. Activities include:Implement and follow procedures to ensure timely and accurate receipt and review of complaint and non-complaint cases. These activities include: Review and check the details of a ServiceMax case (Customer details, Product information, Event Description, Case reason Information and Quality Information) Follow-up with Field Service Engineer (FSE) if additional information is required Ensure the Trackwise codes and Adverse Event questions are answered for a complaint Escalate to APRCC Team Lead if the complaint involves Adverse Event Ensure that the complaint was integrated into TrackWise Check and monitor work order status All related information to the case needs to be entered in case comments For any issue that qualifies as a complaint, ensure the case converted to complaint by FSE Review work order details and related attachments Prepare complaint trend analysis and reports, if needed Verify that the work order does not mention multiple unrelated issues as this would require opening additional complaints to capture the additional issues 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: 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. 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 Supervisor and/or higher management. Prepare and analyze complaint trends for the country/region.. III. Education Diploma or BS Degree desired, preferably in scientific, technical or engineering discipline, or applicable work experience IV. Other Qualifications - Professional Certification/Key Licenses Relevant quality assurance experience in quality systems for complaint management, failure investigation, corrective & preventive action, and document & quality records management. V. Experience Working experience in the pharmaceutical or medical device manufacturing industry is preferred. VI. Required Knowledge and Skills Working knowledge of Quality System standards and regulations ISO 9000:2008, ISO 13485: 2016 or US FDA QSR (21 CFR 803 & 820) will be an advantage. Fluent in spoken and written English. Good communication skills. Must be able to communicate precisely and accurately to all levels of the organization. Continuous and versatile learning. Drive for results and action oriented with a high sense of urgency. Self-starter with the desire and ability to take initiative. Demonstrated ability to work independently under time constraints, manage competing priorities and deadlines, and handle multiple tasks efficiently and effectively. Must be able to identify and resolve problems and requests in a proactive and timely manner. Must be able to gather and analyse information skilfully using problem-solving/root cause analysis skills. Ability to exchange information clearly and concisely. Ability to work for a large, fast-paced, matrix organization with speed and accuracy. Ability to work well in a team-oriented environment. Able to use Microsoft Excel spreadsheet with knowledge of formulas, statistical and modeling tools to identify and improve processes Proficiency in statistical analysis and metrics reporting and associated tools and packages Able to use PowerPoint skills for the creation/maintenance of organization charts and presentations. Provide support to Customer Facing Teams Culture and Benefits Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself.We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority. How To Apply Submit your application by clicking on the \'apply\' button at the top of the page.Primary Work Location MYS Kuala Lumpur - Jalan KerinchiAdditional Locations Work Shift MY2 Standard (Malaysia)

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