CAPA Lead

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities include but are not limited to:

• Own and manage the site CAPA program lifecycle, including initiation, investigation, action planning, implementation, and closure.

• Ensure CAPAs are risk-based, timely, and compliant with internal and regulatory requirements.

• Monitor CAPA effectiveness checks to ensure long-term issue resolution.

• Lead CAPA review boards / governance forums.

• Drive robust problem-solving methodologies (e.g., 5 Whys, Fishbone, Fault Tree, DMAIC).

• Ensure high-quality root cause identification aligned with data and evidence.

• Partner with cross-functional teams (Operations, Quality, Engineering, EHS) to resolve issues.

• Ensure CAPA processes meet FDA (21 CFR Part 820/210/211 as applicable) and GMP expectations.

• Support regulatory inspections, internal audits, and corporate audits.

• Act as SME for CAPA during audits and inspections.

• Track and report CAPA metrics tied to Warning Letter commitments (if applicable).

• Develop and manage CAPA KPIs, including:

o   On-time closure rate

o   Overdue CAPAs

o   Recurrence rate

o   Investigation cycle time

• Provide regular reporting to site leadership and corporate teams.

• Identify trends and drive systemic improvements.

• Champion a proactive quality culture focused on prevention vs. correction.

• Integrate CAPA learnings into Lean / BD Excellence initiatives.

• Lead Kaizen or problem-solving events tied to recurring issues.

Train site personnel on:

o   CAPA process and expectations

o   Root cause analysis tools

o   Investigation best practices

• Ensure consistent quality and standardization of investigations across the site.

• Bachelor’s degree in Engineering, Quality or related field.

• 5+ years of experience in Quality/Manufacturing within a regulated industry (medical device, pharma, or similar)

• 2+ years in CAPA, investigations, or compliance leadership roles.

• Fully Bilingual - English - Spanish

• Strong knowledge of FDA regulations and GMP standards and CAPA systems and quality management systems (QMS)

• Experience with Root cause analysis methodologies, Audit/inspection readiness, Data analysis and trend identification

• Strong cross-functional leadership and influence skills

• Ability to operate in high-pressure, compliance-driven environments

• Excellent communication and executive reporting skills

• Results-driven with strong sense of urgency and accountability

This position is a Fixed Term (limited-term) assignment designed to support a specific business need. Associates in this role are eligible for BD benefits, including medical, dental, health, and 401(k), subject to the eligibility requirements of BD Total Rewards policies. Employment is intended for a defined period and is expected to conclude upon completion of the assignment or fulfillment of the associated business objective