BD (Becton, Dickinson and Company) Quality Systems Lead/Manager in Tuas, Singapore
Job Description Summary
This position is responsible for leading and managing the BD Holdings ISO 13485 Quality Management System; Singapore Office for the Singapore GDPMDS regulatory requirements, and Malaysia Office for the Malaysia GDPMD regulatory requirements in ensuring that the quality systems complies to the requirements of the relevant standards, corporate and local regulation requirements.
This role includes providing Quality Systems management leadership in the Greater Asia region to assure alignment across the region 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.
Maintain the effectiveness of the ISO13485 quality management system in BD Holdings including coordinating the preparation of documents and reports necessary for Management Review
Maintain the effectiveness of GDPMDS quality management system in the Singapore Distribution Center including coordinating the preparation of documents and reports necessary for Management Review.
Maintain the effectiveness of GDPMD quality management system in the Malaysia office including coordinating the preparation of documents and reports necessary for Management Review.
Establish and oversee the Quality Agreement between BD Holdings and the countries in accordance to region Quality Management Systems.
Establish Quality Management System as required to comply with new country regulations in South East Asia.
Ensures that processes, organization, procedures, and activities in the Quality Management System in the Greater Asia region are harmonized and are adequate to effectively meet the needs of the organization and conform to all applicable regulatory requirements, and the Quality Agreement
Initiate, track, follow-up and close Corrective and Preventive Actions.
Takes on the role of site CAPA Lead (i.e. CAPA process subject matter expert), mentors others in investigation and action plan tasks. Evaluates and/or approves all CAPA phases and requests for extensions. Facilitates the CAPA Review Board (CAPA Board) and manages the site CAPA Training process.
Responsible for review and documenting updates when necessary the BD’s quality documents in accordance with quality related regulations, etc.
Responsible for BD Holdings document management system inclusive of disseminating quality procedures and scheduling and tracking associated training.
Takes on the role of BDH Internal Auditor to conduct/support audits according to BDH Audit Schedule/Program to ensure compliance with the applicable procedures.
Executes any other tasks and/or projects as assigned by the regional Quality Manager and Senior Director of Quality, Greater Asia
Primary Work Location
SGP Tuas - Tuas
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.