Quality Specialist

Becton Dickinson Medical Devices • Plainfield, NJ

4d • Onsite

About The Position

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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

• Degree level qualification; or equivalent combination of education and experience.

Responsibilities

• Support the development, implementation, and ongoing maintenance of Quality Management System (QMS) processes to ensure full compliance with FDA 21 CFR 820 and ISO 13485 requirements.
• May serve as a Regional Site CAPA Lead for the North America region, providing leadership and hands-on support for CAPA activities, including investigation management, root cause analysis (RCA), and development and execution of corrective and preventive action plans.
• Provide mentorship and guidance to North America regional teams on QMS requirements, including Nonconformance, Planned Deviations, and Audit processes, while actively contributing to continuous improvement initiatives
• Lead and facilitate monthly North America Region Nonconformance Coach meetings to promote consistency, knowledge sharing, and effective issue resolution.
• Ensure regional procedures for Nonconformance and Planned Deviations are aligned with global procedures and remain compliant with applicable regulatory and quality system standards.
• Support internal and external QMS audits by preparing documentation, participating in audit activities, and driving corrective actions to ensure compliance and continuous improvement.
• Analyze quality metrics and trend data to proactively identify risks, systemic issues, and opportunities for quality improvements related to nonconformances and planned deviations.
• Own and maintain the integrity of nonconformance records, ensuring completeness, accuracy, traceability, and compliance with regulatory and internal requirements.
• Ensure consistent application and adherence to ISO 13485, FDA 21 CFR 820, and Global policies and procedures across all assigned QMS processes.
• Build and maintain strong, collaborative working relationships across all organizational levels, supporting and leading Quality Management System activities and cross‑functional projects as needed.
• May assist in other duties as required.

Benefits

• A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
• It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
• 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.
• Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed