BD (Becton, Dickinson and Company) Quality Systems Leader in Drogheda, Ireland
Job Description Summary
Quality System Leader
BD, a leading global medical technology company that makes and sells medical devices, instrumented systems, and reagents, is dedicated to improving people health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Companies capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs more than 25,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry, and the public.
We have been established in Ireland for 50 years, with manufacturing plants in Drogheda and Dun Laoghaire. The Drogheda operation produces Lancets, Pen Needles, and Pre-Filled Saline Syringes. The manufacturing process involves Moulding, High-Speed Assembly, Packaging and Sterilisation.
We currently have a vacancy for a Quality Systems Leader at our Drogheda site reporting to the Quality Manager. In the role you will lead actively related to the governance of ISO13485 and 21CFR Part 820 Quality Systems and become an active leader of the site internal audit team, liaising with Regulatory auditors
Be a primary contact for other departments providing quality advice / guidance to assure compliance.
Responsible for the internal audit system, including weekly meetings & report outs.
Responsible for the CAPA system, including weekly progress meetings & report outs.
Implement metrics systems for Management Review, including where relevant BOS charts.
Responsible for QA systems and processes to ensure compliance with relevant GMPs and promote quality improvements
Lead quality reviews on a range of quality documentation including, SOPs, Policies, Guidelines, Specifications, Investigations, Complaints, Change Controls, GMP records and other Quality Management Systems Documentation as required.
Responsible for ensuring adherence to internal and external regulatory requirements
Become an active leader of the site internal audit team, liaising with Regulatory auditors
The ideally candidate will have 7+ years in a similar position and extensive experience with ISO13485 and 21CFR Part 820. You will also need experience with QMS internal and external audits.
If you are a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here:http://bd.tal3nt.community/
Primary Work Location
IRL Drogheda - Donore Rd
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.