Regional Quality Compliance Lead – QMS, CAPA & Audits (Onsite)

Becton, Dickinson and Company; Plainfield (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

BD in Indiana (Plainfield) is seeking a Quality Management System specialist to support and maintain QMS processes under FDA 21 CFR 820 and ISO 13485. This role emphasizes CAPA leadership and cross‑functional collaboration.

You will mentor regional teams, lead Nonconformance and Planned Deviations activities, and ensure audits are executed effectively while driving continuous improvement. A degree or equivalent is required, with strong regulatory knowledge and a proactive approach to risk and

Qualifications

• Degree level qualification or equivalent combination of education and experience.
• Experience with FDA 21 CFR 820 and ISO 13485 is preferred.
• Knowledge of Nonconformance and Planned Deviations processes.

Responsibilities

• Support QMS processes to meet FDA 21 CFR 820 and ISO 13485 requirements.
• Lead CAPA activities, including investigations and RCA.
• Mentor NA regional teams on QMS requirements and audits.
• Lead monthly North America Nonconformance Coach meetings.
• Ensure regional procedures align with global QMS standards.
• Assist with internal and external QMS audits and corrective actions.
• Analyze quality metrics to identify risks and improvements.
• Maintain nonconformance records with accuracy and traceability.
• Promote ISO 13485, FDA 21 CFR 820 compliance across processes.
• Collaborate cross-functionally on QMS projects.
• May assist in other duties.

Skills

Quality Management

CAPA & RCA

Regulatory Compliance

Audit Readiness

Cross-functional Leadership

Education

Bachelor's degree or equivalent

Job description

BD in Indiana (Plainfield) is seeking a Quality Management System specialist to support and maintain QMS processes under FDA 21 CFR 820 and ISO 13485. This role emphasizes CAPA leadership and cross‑functional collaboration.

You will mentor regional teams, lead Nonconformance and Planned Deviations activities, and ensure audits are executed effectively while driving continuous improvement. A degree or equivalent is required, with strong regulatory knowledge and a proactive approach to risk and