QMS & CAPA Lead — Quality Specialist

BD; Four Oaks (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

BD is seeking a Quality Management System (QMS) professional to support, lead, and maintain QMS processes across North America in strict compliance with FDA 21 CFR 820 and ISO 13485. The role includes serving as Regional CAPA Lead, guiding audits, nonconformances, deviations, and continuous improvement with a focus on on-site collaboration.

The ideal candidate will mentor regional teams, ensure alignment with global procedures, and drive corrective actions.

Qualifications

• Must have degree or equivalent combination of education and experience.

Responsibilities

• Support development, implementation, and maintenance of QMS processes for FDA 21 CFR 820 and ISO 13485 compliance.
• Serve as Regional Site CAPA Lead for North America with investigation management, RCA, and corrective/preventive actions.
• Mentor NA regional teams on QMS requirements including Nonconformance, Planned Deviations, and Audit processes.
• Lead monthly NA Region Nonconformance Coach meetings for consistency and issue resolution.
• Ensure regional procedures align with global standards and regulatory requirements.
• Support internal and external QMS audits; prepare documentation and drive corrective actions.
• Analyze quality metrics to identify risks and opportunities for improvement in nonconformances and planned deviations.
• Maintain integrity of nonconformance records with traceability and regulatory compliance.
• Ensure ISO 13485, FDA 21 CFR 820, and Global policies are consistently applied across QMS processes.
• Build collaborative relationships across all levels and cross-functional projects.
• May assist in other duties as required.

Skills

QMS knowledge

CAPA leadership

Regulatory compliance

Education

Degree level qualification or equivalent

Job description

BD is seeking a Quality Management System (QMS) professional to support, lead, and maintain QMS processes across North America in strict compliance with FDA 21 CFR 820 and ISO 13485. The role includes serving as Regional CAPA Lead, guiding audits, nonconformances, deviations, and continuous improvement with a focus on on-site collaboration.

The ideal candidate will mentor regional teams, ensure alignment with global procedures, and drive corrective actions.