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.

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