BD (Becton, Dickinson and Company) Quality Engineer II in Tuas, Singapore
Job Description Summary
Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.Key Responsibilities
•Ensures proper design and development control and its documentation as per ISO 13485/ FDA QSR Quality System.
•Leads or supports Risk Management in accordance with ISO14971.
•Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, safe, and professional manner.
•Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/ 21 CFR 820 Quality System/ EN requirements.
•Supports continuous improvement of the Quality Systems.
•Applies Six Sigma methodology to support product development process.
•Provides QS knowledge to organization as needed. Administers appropriate training as needed.
•Participates in the ongoing operations of QA/QS activities
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.