BD (Becton, Dickinson and Company) Quality Engineer in Drogheda, Ireland
Job Description Summary
Operating as part of the Quality Team providing leadership, knowledge and expertise in the area of quality and assurance for the MPS Business Unit in BD Drogheda; whilst also supporting other activities in relation to Quality Engineering and Quality Systems
Management of the non-conformance process, including containment, root cause analysis and product disposition.
Plan, document and implement process validations in accordance with best industry standards and corporate templates.
Support Process Engineers in validation and change management activities.
Act as plant representative during Design Transfer and Design Review meetings with Unit QA & R&D.
Compilation and reporting of quality metrics to Unit Quality.
Responsible for managing the disposition of non-conforming components with material suppliers.
Drive Quality Improvement Plans at the Drogheda site, to reduce QNs and customer complaint occurrence.
Responsible for CAPA ownership and timely and thorough execution of CAPA’s.
Ensure compliance of the Quality System with all applicable medical device regulations as well as the MPS and BD Corporate Quality System.
Act as a member of the Internal Audit team, conducting internal audits per the annual schedule.
Support the investigation of customer complaints as required.
Support the batch release process and release function.
Preparation of Quality reports for quality meetings and management reviews.
Active participation in all Local and World Wide MPS quality meetings.
Contribute to plant maintaining ongoing compliance with ISO13485.
Act as Subject Matter Expert for Notified Body/Regulatory Audits.
Support Quality Engineering/Continuous Improvement activities as required.
Ensure adherence to all BD regulatory requirements.
Liaising with both internal and external customers on quality issues.
Promotion of Quality Awareness and cGMP within the Plant.
Training of associates on Quality procedures and initiatives
SOP writing and maintenance.
- Degree Qualified in Engineering, Science or Quality related discipline.
4+ Years relevant work experience in a regulated medical device or pharmaceutical environment- with exposure to ISO 13485 & 21CFR 820.
Strong Understanding of GMP
Experience of filling, packaging and process validation
Six Sigma qualification an advantage
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.