Quality Systems Lead - CAPA & QMS (FDA/ISO)

Regulatory Jobs; Plainfield (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Becton, Dickinson, and Company (BD) is seeking a QMS-focused professional to support and enhance our Quality Management System across North America. You will drive CAPA activities, advise regional teams on ISO 13485 and FDA 21 CFR 820, and ensure our processes remain compliant while enabling continuous improvement.

The role requires on-site collaboration in Plainfield, Indiana, with opportunities to influence global quality programs.

Qualifications

• Degree level qualification or equivalent experience in quality/regulatory field.
• Experience with FDA 21 CFR 820 and ISO 13485 is required.
• Willingness for on-site collaboration in North America.

Responsibilities

• Support QMS processes to ensure FDA 21 CFR 820 and ISO 13485 compliance.
• Lead CAPA activities including RCA and corrective actions.
• Mentor regional teams on QMS requirements.
• Lead Nonconformance and Planned Deviations processes.
• Prepare documentation for QMS audits.
• Analyze quality metrics to identify improvement opportunities.
• Maintain nonconformance records with traceability.
• Align regional procedures with global standards.
• Collaborate cross-functionally across the organization.

Skills

QMS compliance

CAPA leadership

RCA analysis

Audit support

FDA 21 CFR 820

ISO 13485

Documentation control

Regulatory knowledge

Mentorship

Education

Bachelor's degree or equivalent

Job description

Becton, Dickinson, and Company (BD) is seeking a QMS-focused professional to support and enhance our Quality Management System across North America. You will drive CAPA activities, advise regional teams on ISO 13485 and FDA 21 CFR 820, and ensure our processes remain compliant while enabling continuous improvement.

The role requires on-site collaboration in Plainfield, Indiana, with opportunities to influence global quality programs.