CAPA Lead
Core
Lead the site CAPA program lifecycle, drive root cause analysis, and ensure compliance with FDA/GMP regulations for a global medical technology company.
Role type
Quality Lead (CAPA & Investigations)
Builds
Quality management systems and regulatory compliance for medical devices
Domain
Medical Technology / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA lifecycle management, root cause analysis (5 Whys, Fishbone, DMAIC), FDA 21 CFR Part 820/210/211 knowledge, GMP standards, audit readiness, KPI development, cross-functional leadership, bilingual communication (English/Spanish)
Preferred skills
Lean / BD Excellence initiatives, Kaizen event leadership, trend identification, executive reporting
Technologies
QMS systems, data analysis tools
Responsibilities
Own and manage the site CAPA program lifecycle, drive robust problem-solving methodologies, ensure CAPA processes meet FDA and GMP expectations, develop and manage CAPA KPIs, train site personnel on CAPA processes and root cause analysis tools
Seniority
Mid-Senior, hands-on IC