Job Description Summary
As a Senior Quality System Specialist, you will play a central role in maintaining and improving quality systems to ensure alignment with global regulatory standards. Working closely with others, you will support quality operations across multiple BD entities and contribute to ongoing compliance and audit readiness. The position requires collaboration across various functions, a structured approach, and a strong understanding of medical device quality system requirements.In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.
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!
Main responsibilities will include:
- Maintain and improve quality management system (QMS) processes in accordance with FDA 21 CFR 820, ISO 13485, MDR, and MDSAP requirements
- Prepare, update, and support quality agreements across different BD legal entities
- Collect and maintain QMS scorecards following internal quality procedures
- Support the planning and execution of internal and external audits, including non-conformance closure
- Contribute to management review activities for legal manufacturers
- Lead non-conformances and CAPAs linked to your area of responsibility
- Analyse and trend data to support MDSAP jurisdiction requirements
- Implement and support continuous improvement initiatives related to QMS
About you:
- Hold a relevant degree and bring proven experience in quality or compliance ideally within the medical technology sector
- Have previous experience working in an FDA-regulated environment
- Demonstrate sound knowledge of ISO 13485, 21 CFR 820, MDR, and MDSAP regulations
- Communicate clearly and professionally in both written and spoken English
- Organise and prioritise tasks effectively, with strong attention to detail
- Use Microsoft Office tools with confidence and accuracy
Click on apply if this sounds like you!
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
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