Becton, Dickinson and Company

CAPA Lead

Becton, Dickinson and Company$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Quality, or a 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 in English and Spanish.
  • Strong knowledge of FDA regulations, GMP standards, and CAPA systems.

Responsibilities

  • Own and manage the site CAPA program from initiation to closure.
  • Ensure CAPAs are timely and compliant with internal and regulatory standards.
  • Lead CAPA review boards and governance forums.
  • Drive robust problem-solving methodologies for issue resolution.
  • Partner with cross-functional teams to address and resolve issues.
  • Develop and manage CAPA KPIs and provide regular performance reports.
  • Champion a proactive quality culture focused on prevention.

Benefits

  • Training site personnel on CAPA processes and best practices.
  • Opportunity to lead Kaizen or problem-solving events.
  • Engagement in Lean/BD Excellence initiatives for continuous improvement.
  • Cross-functional collaboration with teams across the organization.
Full Job Description
Job Description

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.


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


Required Skills

Optional Skills

Primary Work Location
USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ

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