Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
We are looking for a Quality Engineer II, for our facility in BD Enniscorthy. You will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends. The successful candidate will collaborate with cross functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures. This position plays an integral role in maintaining compliance with global regulations. The role will work closely with different functions onsite and between other BD sites in Europe and the US.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us!
Our vision for Peripheral Intervention (PI) at BD
Our Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.
About the role
As Quality Engineer Post Market Surveillance you will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends.
The successful candidate will collaborate with cross functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures. This position plays an integral role in maintaining compliance with global regulations. The role will work closely with different functions onsite and between other BD sites in Europe and the US.
Main responsibilities will include:
- Work with a team to meet the requirements in generating periodic PMS related reports
- Identify development and training opportunities for PMS team along with Manager
- Participate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissions
- Identify gaps and maintain PMS processes in compliance with global regulations
- Participate in PMS planning and reporting
- Extract and generate PMS and operational performance data necessary for generating applicable reports.
- Coordinate and provide oversight in the analysis of PMS data
- Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity
- Identify and evaluate new failure modes when encountered
- Support responding to requests for additional information from competent authorities, registries and notified bodies
- Work cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfil ad-hoc data requests and deliver detailed analysis of PMS data
- Develop and maintain knowledge of support systems including Master Control, JDE
About you
- Requires a minimum of a bachelor’s degree, Engineering Degree, or degree in a technical field
- Experience in technical writing and project management is needed
- Proficient in Excel in manipulation of data
- Minimum of 3 years relevant experience or a combination of equivalent education and relevant experience.
- Proficient in Windows OS, Microsoft Office Suite, particularly PowerPoint
- Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and EU MDR
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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, military eligibility or veteran status, or any other protected status.
To learn more about BD visit: https://bd.com/careers
Required Skills
Optional Skills
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Primary Work Location
IRL Wexford - EnniscorthyAdditional Locations
Work Shift
Success Profile
What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Collaborative
- Conceptual
- Creative
- Imaginative
- Problem-solver
- Team player
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.