Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
-
Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
You will support manufacturing of peripheral interventional devices. This role will represent quality interests and concerns on day-to-day quality operations to ensure conforming materials are available for manufacturing and customers. You will work on problem solving and investigations to determine root cause of material non-conformances so that issues are resolved to close out with no recurrences. The role will work closely with the different functions.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 BD's trajectory while leaving a legacy.
To find purpose in the possibilities, we need people who can see the bigger picture and 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 where 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 at BD
Our Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for treating peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.
About the role
As a Quality Engineer, you will support manufacturing peripheral interventional devices. This role will represent quality interests and concerns on day-to-day quality operations to ensure conforming materials are available for manufacturing and customers. You will work on problem-solving and investigations to determine the root cause of material non-conformances so that issues are resolved and closed with no recurrences. The role will work closely with the different functions.
Main responsibilities will include:
- Ensures compliance with quality system requirements as defined by BD Technologies, procedures, FDA QSR, ISO 13485, and applicable international and national standards (e.g., EN, ASTM).
- Provides Quality representation to support the day-to-day operation of the business
- Experience in risk management tools, specifically PFMEA, and how process changes can impact existing risk assessments.
- Experience in validation, including assessing the impact of changes to existing processes and the review and approval of process validation documentation (IQ, OQ and PQ)
- Ensuring continued material compliance and timely disposition of non-conforming materials from Incoming Quality Control or Manufacturing Processes.
- Demonstrated experience in the use of root cause analysis tools and problem-solving techniques.
- Supports continuous improvement initiatives related to quality processes to drive performance and compliance.
- Demonstrated experience in change control systems, including creating/updating various documents or procedures and reviewing quality documentation to ensure accuracy and compliance with procedures and regulations.
- Demonstrated ability to use data analysis to drive solutions that can improve the quality of a process, such as NCMR reduction, defect reduction, inspection improvements, etc.
- Supports metrics and regulatory reporting following the relevant Corporate, Local and International Requirements.
About you
- Minimum third-level qualification (Degree level), preferably science or engineering.
- 3 Years of Experience in a Regulated Industry, including QA, compliance, and/or Regulatory Affairs.
- Strong working knowledge of QSR, ISO 13485 MDR and FDA requirements.
- Experience conducting quality audits and inspections is desirable.
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on race, colour, 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
.
Primary Work Location
IRL Wexford - EnniscorthyAdditional Locations
Work Shift
Success Profile
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Ambitious
- Collaborative
- Goal-oriented
- Persuasive
- Results-driven
- Self-starter
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.