Quality Specialist

BD; Plainfield (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

BD is seeking a Regulatory Quality Manager to develop, implement, and maintain QMS processes ensuring FDA 21 CFR 820 and ISO 13485 compliance across North America. This role may act as the CAPA lead, guiding investigation management, RCA, and corrective actions while mentoring regional teams.

The position emphasizes audit support, process improvement, and data-driven quality initiatives, with a focus on nonconformances, planned deviations, and regulatory alignment across the organization.

Qualifications

• 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 preventative 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.

Job description

We Are The People Who Give Possibilities Purpose

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.

Responsibilities

Job Description

• 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 preventative 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.

Minimum Requirement

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

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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA IN - Plainfield

Additional Locations

USA NC - Four Oaks

Work Shift