We are the people who give possibilities purposeBD 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 DescriptionResponsibilities include but are not limited to:CAPA Management & GovernanceOwn 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 AnalysisDrive 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 ReadinessEnsure 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 & MetricsDevelop and manage CAPA KPIs, including: o On-time closure rateo Overdue CAPAso Recurrence rateo Investigation cycle timeProvide regular reporting to site leadership and corporate teams.Identify trends and drive systemic improvements.Continuous ImprovementChampion a proactive quality culture focused on prevention vs. correction.Integrate CAPA learnings into Lean / BD Excellence initiatives.Lead K
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