CAPA Lead

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:
  • On-time closure rate
  • Overdue CAPAs
  • Recurrence rate
  • 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:
  • CAPA process and expectations
  • Root cause analysis tools
  • Investigation best practices
• Ensure consistent quality and standardization of investigations across the site.

Education:

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

Experience:

• 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.

Knowledge and Skills

• 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

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](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.