BD (Becton, Dickinson and Company) Senior Quality Specialist / Quality Executive in Kuala Lumpur, Malaysia
Job Description Summary
This position is responsible for leading and managing the ISO 13485 Quality Management Systems for BD Greater Asia Shared Service Centre in Malaysia and AP Shared Service Centre in Singapore, to ensure the quality systems complies with the requirements of the relevant standards, corporate and local regulation requirements.
This role includes providing Quality management leadership to the Shared Services Centers to assure alignment with GA Head Office, and that the Quality System and processes adequately support the activities and priorities in order to provide an effective and efficient quality system that creates customer value addressing elements critical to Business success, continuity and competitive advantage.
Leading and managing the ISO 13485 Quality Management Systems for Greater Asia Shared Services Center and Asia Pacific Shared Services Center.
Maintain, review and approve Quality System Procedures and ensure contents are appropriate to maintain the effectiveness of the Quality Management Systems.
Work and coach the relevant functions in order to ensure compliance to Quality Management System requirements.
Coordinate and prepare the relevant functions in preparation for Internal, External and Corporate Audits. Follow up on any actions arising from the audits. Initiate, track, follow-up and close Corrective and Preventive Actions for all nonconformance in shared service centers.
Initiate and follow-up change control requests to ensure compliance to the relevant process for changes relating to Quality Management Systems and Shared Services.
Facilitates and coordinates the Risk Management process within Greater Asia Shared Services Centers.
Maintain the effectiveness of ISO13485 quality management system in the Shared Services offices including coordinating the preparation of documents and reports necessary for Management Review.
Subject matter expert (SME) on CAPA and Validation for the Greater Asia and Asia Pacific Shared Service centers.
Assumes the role of Internal Auditor to conduct or support audits according to Internal Audit Schedule to ensure compliance with the applicable standards (e.g. ISO 13485), regulatory requirements (GDPMD) and BD procedures.
Executes any other tasks and/or projects as assigned by the regional Quality Manager
Primary Work Location
MYS Kuala Lumpur - Jalan Kerinchi
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.