BD (Becton, Dickinson and Company) Quality Engineer in Wexford, Ireland
Job Description Summary
Working in Quality Operations supporting manufacturing with investigations and process improvements.
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).
Main responsibilities will include:
Participates in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non-conformances so that issues are resolved to close out with no recurrences.
Ensures compliance to quality system requirements as defined by BD Enniscorthy's’ procedures, FDA QSR, ISO 13485 and applicable international and national standards (e.g. EN, ASTM) through active participation in the divisional and cross divisional product and process development system
Provides Quality Engineering representation on cross-functional product development teams
Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance
Leads cross-functional teams to develop risk assessments and risk controls
Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods
Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups
Applies risk management, change control, and validation principles throughout the product lifecycle
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.
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