Quality Specialist

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.

Minimum Requirement

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

Additional information

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.