We are the people who give possibilities purpose. We are the makers of possible. BD is one of the largest global medical technology companies in the world, advancing the world of healthTM. We believe that the human element, across our global teams, is what allows us to continually evolve.
Requirements
- 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.
- 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.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
