BD (Becton, Dickinson and Company) Quality Systems Engineer in Dun Laoghaire, Ireland
Job Description Summary
Reporting to the Quality Systems Manager, duties will include implementing & maintaining the Company’s Quality Management System in accordance with ISO 13485 and FDA CFR 21 Part 820.
Our facility in Dun Laoghaire has recently completed a large expansion plan and now produces the majority of pen needles for the diabetes market globally. We currently have approximately 460 associates. We are now ramping up to commence producing the newest BD product to support the diabetes market.
The role of the Quality Systems Engineer is to investigate product complaints & identify corrective action. This role works cross-functionally to investigate and address customer complaints. You will monitor plant wide complaints on all products and analyse the trends of these complaints. This role reports to the senior management team and leads high-level complaint investigations with operations to ensure appropriate actions are taken to prevent reoccurrence of issues.
In order to complete this role, you must have an excellent technical knowledge. Part of this role is to work with other BD sites to evaluate and investigate new product complaints
You will perform plant wide trending and analysis of complaint performance. You will Interpret results and identify required actions. A requirement of this position is to deliver overviews of complaint performance to site and unit management. You will periodically review the Customer Complaint management process for improved efficiencies and to assure continued compliance.
You will provide a quality review on a range of quality documentation including procedures, records and investigations. This role has responsibility to approve customer complaint investigations. As part of this position, you will act as a representative of Customer Complaints for all third-party audits. This person is a key driver of cGMP practices within Operations and Quality. You must manage compliance with relevant GMPs and promote quality improvements. You are an active member of the site internal audit team.
The successful candidate will have a minimum of 5 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices / Pharmaceutical industry. You will have a third level scientific or engineering degree. You will be experienced in technical writing and review. The ideal candidate will have proven ability to lead and working in a cross-functional team environment. Excellent interpersonal and communication skills is a key criterion for this role. You will have proven analytical and technical thinking skills. You will have previous experience of customer complaint management. You need to have the ability to work progressively as part of a team and on your own initiative. You will have excellent documentation skills and attention to detail. You will be able to work on your own initiative and follow through. You will be an excellent communicator who can interact with all levels of colleagues and bring cross team working to its fullest potential.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast-moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Primary Work Location
IRL Dun Laoghaire - Pottery Road
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.