Quality Systems & CAPA Leader - On-Site QMS Expert

BD; Plainfield (IN); In loco; USD 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Descrizione del lavoro

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.