BD (Becton, Dickinson and Company) Quality Engineer II in Wexford, Ireland
Job Description Summary
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
At the Enniscorthy facility, BD manufactures mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are now recruiting a Quality Engineer II to join our team on a permanent basis in a Day role (Monday to Friday).
About the role
Reporting to the Senior Quality Assurance, you will represent quality interests and concerns in conjunction with a cross functional team. Perform and provide input into qualification activities including TMV, IQ, OQ, PQ. Provide supplier quality activities, leading risk management activities in conjunction with the team.
Main responsibilities will include:
Lead the Quality engineering activities in conjunction with a multi-functional team as required.
Develop process risk management documentation with cross-functional support.
Develop or assist in development of inspection and test methods per product specifications.
Perform test method validations and component qualifications as required.
Perform DOE’s and other statistical analysis to support product and process optimisations or settle causes of process variation. Initiate corrective actions as required.
Provide quality support to inspectors to ensure resolution to issues identified on supplied material.
Work with suppliers to ensure robust corrective actions are implemented as required.
Participate in supplier audit programme as required.
Participate in internal audit and CAPA programmes.
Develop robust action plans, projects and verification activities for elimination of potential non-compliance and CAPA related risks, as required.
Align quality system with changes in global and corporate quality management standards, policies and regulations.
Identify quality systems engineering improvement opportunities and executes through the change management system.
The successful candidate will have a minimum of 5 years’ experience, coupled with a background in Medical Devices/Pharmaceutical Industry. Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. The ideal candidate will hold a degree in an Engineering/Technical/ Science field.
The ideal candidate will have solid understanding of change control, non-conformance, CAPA & statistical software (Minitab). Also, knowledge of DMAIC process or other similar problem-solving techniques.
You will have experience of preparing risk management documentation - e.g. pfmea; Gauge R&R and Test Method Validation. You will have Lead Auditor qualification and experience (internal & external).
This role requires ability to work under own initiative to consistently meet targets and deadlines, attention to detail, flexibility and excellent organisational skills.
Click on apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work Location
IRL Wexford - Enniscorthy
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.