Becton, Dickinson and Company

Senior Quality Engineer - CAPA

Becton, Dickinson and Company • $95K — $115K *
Covington, GA 30016In-Person
Healthcare
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Science, or related technical field
  • Minimum of 6 years of experience in engineering or quality systems
  • Strong understanding of ISO 9001, ISO 13485, FDA QSR, and EU MDR
  • Experience in regulated industries such as medical devices or pharmaceuticals
  • Demonstrated ability to lead Quality System processes, particularly CAPA

Responsibilities

  • Serve as primary SME for CAPA processes organization-wide
  • Provide coaching on investigations and effectiveness verification activities
  • Monitor CAPA performance and ensure timely completion of action plans
  • Analyze process nonconformances for corrective action development
  • Collaborate with teams to ensure quality issues are effectively managed
  • Perform data analysis to identify trends and opportunities for improvement
  • Champion continuous improvement initiatives throughout quality systems

Benefits

  • Opportunities for professional development and advancement
  • Collaborative work environment with cross-functional teams
  • Access to industry-related training and certifications
  • Support for participation in industry organizations
  • Contributions to meaningful quality and compliance improvements
Full Job Description
Job Description

Position Summary

The Senior Quality Systems Engineer - CAPA & Continuous Improvement serves as a subject matter expert (SME) for Quality Systems with primary responsibility for the Corrective and Preventive Action (CAPA) process. This role is responsible for driving CAPA effectiveness, improving quality system performance, and ensuring compliance with applicable regulatory requirements and company standards.

The successful candidate will provide technical guidance, coaching, analytics, and continuous improvement support across the organization while partnering with cross-functional teams to ensure quality issues are effectively investigated, corrective actions are implemented, and quality system processes continue to improve. This position also serves as a key resource for Quality Systems requirements, root cause analysis, compliance initiatives, and quality performance reporting.

Key Responsibilities
CAPA Leadership & Quality Systems
  • Serve as the Subject Matter Expert (SME) for CAPA processes across the organization.
  • Provide guidance and coaching on investigations, root cause analysis methodologies, corrective actions, CAPA documentation, and effectiveness verification activities.
  • Monitor CAPA performance and ensure corrective action plans are completed accurately, effectively, and on time.
  • Analyze process nonconformances and support the development and implementation of corrective and preventive actions.
  • Provide leadership and support for the timely communication and escalation of significant CAPA-related issues to Quality Leadership and Business Unit leaders.
  • Collaborate with Post Market Quality to ensure timely completion of nonconformance escalation activities and Situation Analysis reviews.
  • Apply Quality Systems principles including CAPA, document control, and related quality processes to support business objectives.
  • Provide work direction, mentoring, and support to CAPA owners and project teams as needed.

Data Analytics & Reporting
  • Perform data analysis related to CAPA and Quality Management System (QMS) performance to identify trends, risks, and improvement opportunities.
  • Develop, maintain, and present quality metrics, KPIs, dashboards, and reports for management and senior leadership.
  • Utilize statistical tools and methodologies, including Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE), to evaluate process effectiveness and support data-driven decision-making.
  • Support CAPA effectiveness verification activities through statistical analysis, sampling methodologies, and objective evidence.
  • Deliver timely and meaningful reports to senior leadership regarding quality system performance and compliance.

Continuous Improvement
  • Champion continuous improvement initiatives that enhance quality system effectiveness, compliance, and operational performance.
  • Collaborate with CAPA stakeholders across multiple sites to standardize best practices and drive global process improvements.
  • Influence cross-functional teams to adopt consistent methodologies, processes, and quality tools across the organization.
  • Implement improvements to quality systems, processes, and documentation to increase efficiency and effectiveness.
  • Support innovation and quality excellence through the application of data-driven problem-solving methodologies.

Compliance & Quality Programs
  • Support the development, maintenance, and continuous improvement of quality programs to ensure compliance with company policies, regulatory requirements, and industry standards.
  • Create, review, revise, and approve Quality System documentation.
  • Ensure compliance with approved quality methods, Good Documentation Practices (GDP), and quality system procedures.
  • Assist with internal audits, external audits, regulatory inspections, and resolution of associated findings.
  • Support post-market surveillance activities and quality-related projects as assigned.
  • Represent the Quality organization professionally during internal and external interactions.
  • Participate in industry and professional organizations as appropriate.
  • Assist with special projects and perform other duties as assigned.

Required Qualifications
  • Bachelor's degree in Engineering, Engineering Technology, Science, or a related technical field.
  • Minimum of 6 years of engineering, quality, or quality systems experience.
  • Strong understanding of quality systems regulations and standards, including:
    • ISO 9001
    • ISO 13485
    • FDA Quality System Regulations (QSR)
    • EU MDR
  • Experience working within regulated industries such as medical device, pharmaceutical, biotechnology, or similar environments.
  • Ability to work effectively in a team-oriented environment and deliver on cross-functional objectives.
  • Experience owning or managing Quality System processes, particularly CAPA.
Preferred Qualifications
  • Experience driving process, product, or quality system improvements.
  • Experience with TrackWise or similar electronic Quality Management Systems (eQMS).
  • ASQ Certification (CQE, CSQE, CQA, or related certification).
  • Lean Six Sigma Green Belt or Black Belt certification.

Knowledge & Skills
  • Experience with electronic CAPA management systems (eCAPA).
  • Experience managing CAPA processes in regulated industries such as medical devices, pharmaceuticals, or biotechnology.
  • Strong root cause analysis and problem-solving skills.
  • Advanced Microsoft Excel capabilities, including Pivot Tables, charts, reports, queries, and data analysis.
  • Strong applied statistics knowledge and experience using statistical tools to improve process capability and support quality investigations.
  • Understanding of sampling methodologies used for CAPA effectiveness verification.
  • Strong understanding of auditing principles and quality compliance requirements.
  • Ability to analyze complex data and translate findings into actionable recommendations.
  • Ability to present data and recommendations effectively to senior leadership.
  • Extensive knowledge of Quality Management Systems and cross-functional business relationships.
  • Excellent communication, collaboration, and influencing skills.
  • Strong organizational and project management capabilities.
  • Ability to work independently while effectively partnering with stakeholders across all levels of the organization.

What Makes You Successful
  • Ability to lead and influence quality improvements without direct authority.
  • Strong analytical mindset with a passion for solving complex quality issues.
  • Commitment to continuous improvement and operational excellence.
  • Ability to coach and mentor others on CAPA, investigations, and quality system requirements.
  • Strong attention to detail and commitment to compliance.
  • Collaborative approach to working across functions, sites, and leadership teams.


Primary Work Location
USA GA - Covington BMD

Additional Locations

Work Shift
US BD 1st Shift 8am-430pm (United States of America)

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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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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