Quality Systems Specialist CAPA, Audit and Compliance

Becton Dickinson NA; Plainfield (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

BD is seeking a Quality Management professional to support development, implementation, and ongoing maintenance of QMS processes ensuring compliance with FDA 21 CFR 820 and ISO 13485. The role includes regional CAPA leadership, investigation management, RCA, and driving corrective actions.

You will mentor North America regional teams on QMS requirements, coordinate Nonconformance and Planned Deviations, and lead cross-functional programs to improve quality and compliance.

Qualifications

• Degree level qualification or equivalent combination of education and experience.
• Experience implementing and maintaining QMS processes.

Responsibilities

• Support development and maintenance of QMS processes to ensure FDA 21 CFR 820 and ISO 13485 compliance.
• Lead regional CAPA activities including investigation management and RCA.
• 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 QMS procedures and regulatory requirements.
• Support internal and external QMS audits and drive corrective actions.
• Analyze quality metrics to identify risks and opportunities for improvement.
• Maintain integrity of nonconformance records and regulatory traceability.
• Ensure adherence to ISO 13485, FDA 21 CFR 820, and BD policies across QMS processes.
• Collaborate cross-functionally to support QMS activities and projects.

Skills

QMS understanding

FDA 21 CFR 820

ISO 13485

CAPA leadership

Root cause analysis

Audit support

Education

Bachelor's degree or equivalent

Job description

BD is seeking a Quality Management professional to support development, implementation, and ongoing maintenance of QMS processes ensuring compliance with FDA 21 CFR 820 and ISO 13485. The role includes regional CAPA leadership, investigation management, RCA, and driving corrective actions.

You will mentor North America regional teams on QMS requirements, coordinate Nonconformance and Planned Deviations, and lead cross-functional programs to improve quality and compliance.