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The CAPA Lead is responsible for managing the site CAPA program lifecycle, ensuring compliance with FDA and GMP requirements. This includes leading root cause investigations, managing governance forums, and tracking performance metrics to drive systemic quality improvements.
Candidates must have a Bachelor's degree in Engineering or Quality and at least 5 years of experience in a regulated industry, with 2+ years specifically in CAPA leadership. Proficiency in English and Spanish and strong knowledge of FDA regulations and problem-solving methodologies are required.
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:
CAPA Management & Governance
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.
Investigations & Root Cause Analysis
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.
Compliance & Audit Readiness
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).
Performance Management & Metrics
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.
Continuous Improvement
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.
Training & Capability Building
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
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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BD is the world's largest manufacturer and seller of medical equipment.
BD is one of the world's largest medical technology companies that produce and sell medical equipment, medical systems and reagents, dedicated to improving human health around the world. BD focuses on improving drug treatment, improving the quality and speed of diagnosis of infectious diseases, and promoting the research and discovery of new drugs and vaccines. BD has strong research and development capabilities to fight many of the world's most intractable diseases. Founded in New York in 1897, the company is headquartered in Franklin Lake, New Jersey, USA and employs more than 25000 people in about 50 countries around the world. The company's clients include medical institutions, life sciences research institutes, clinical laboratories, industrial units and the general public.
Offices: 纽约, 10001, US
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