CAPA Engineer
We are the people who give possibilities purpose
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.
Job Description
The CAPA Engineer is responsible for leading and facilitating the Corrective and Preventive Action (CAPA) process to ensure effective resolution of quality issues, nonconformances, audit findings, complaints, and other quality events. This role drives investigations, performs and facilitates root cause analysis, develops robust corrective and preventive actions, verifies effectiveness, and ensures compliance with applicable regulatory requirements and company procedures.
The CAPA Engineer partners closely with Manufacturing, Quality, Regulatory Affairs, Engineering, Supply Chain, and Operations teams to identify systemic issues, drive sustainable improvements, and maintain a state of regulatory readiness. Responsibilities align with CAPA owner and investigator expectations, including thorough investigations, establishment of action plans, effectiveness verification, and maintenance of CAPA documentation.
This position is a Fixed Term (limited-term) assignment from 10/1/26 to 10/1/27 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.
CAPA Management
Lead CAPA investigations from initiation through closure.
Ensure CAPAs are completed on time and comply with internal procedures and regulatory requirements.
Facilitate cross-functional investigation teams.
Maintain CAPA records and supporting documentation within electronic quality management systems (e.g., TrackWise).
Monitor CAPA status and escalate risks, delays, or resource constraints when necessary.
Root Cause Analysis
Conduct and facilitate root cause investigations using appropriate methodologies, which may include
5 Whys
Fishbone (Ishikawa)
DMAIC
SOLV
PDCA
Ensure investigations are evidence-based, systematic, and adequately documented.
Determine true root causes and contributing factors.
Corrective and Preventive Actions
Develop effective corrective and preventive action plans.
Collaborate with process owners to implement sustainable solutions.
Evaluate proposed actions for effectiveness and regulatory compliance.
Verify implementation and completion of assigned actions.
Ensure actions address both immediate and systemic causes.
Effectiveness Verification
Define objective effectiveness criteria.
Perform effectiveness checks to confirm actions have mitigated or eliminated root causes.
Analyze post-implementation data and trends.
Recommend additional actions when effectiveness criteria are not met.
Metrics and Continuous Improvement
Monitor CAPA performance metrics, aging, and effectiveness.
Identify recurring quality issues and systemic trends.
Support continuous improvement initiatives and quality system enhancements.
Develop management reports and quality review presentations.
Regulatory and Compliance Support
Support internal, external, customer, and regulatory audits.
Provide CAPA documentation and investigation support during inspections.
Ensure compliance with:
21 CFR Part 820 / QMSR
ISO 13485
Company Quality System Procedures
Support inspection readiness activities.
Qualifications
Education
Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related technical discipline.
Experience
3 to 7 years of experience in Quality Engineering, Quality Systems, Manufacturing Quality, or CAPA management.
Medical device, pharmaceutical, biotechnology, or regulated industry experience preferred.
Experience leading investigations and root cause analysis activities.
Technical Skills
CAPA Management Systems (TrackWise preferred)
Root Cause Analysis methodologies
Risk Management principles
Data analysis and trending
Quality System Regulations
Statistical tools and quality improvement methods
Microsoft Office and reporting tools
Competencies
Strong analytical and critical thinking skills
Excellent investigation and problem-solving abilities
Ability to influence cross-functional teams without direct authority
Effective project management and prioritization skills
Strong written and verbal communication
Attention to detail and documentation quality
Ability to manage multiple priorities in a fast-paced environment
Why Join Us?
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.
Required Skills
Optional Skills
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