Senior Quality Engineer - Endoluminal Systems
Core
Oversees end-to-end quality investigations, risk management, and continuous improvement for the Endoluminal product family, spanning manufacturing, supplier operations, and new product development.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Endoluminal product family quality outcomes and compliance
Domain
Medical Devices / Endoluminal Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality investigations, risk assessment, CAPA management, regulatory compliance (GMP/ISO/FDA), data analysis, mechanical assembly knowledge, NPI support, cross-functional leadership
Preferred skills
Mentorship, stakeholder influence, continuous improvement project ownership
Technologies
GMP, ISO, FDA standards
Responsibilities
Lead critical product and process investigations and audits; Own quality investigations for complaints and non-conformances; Drive corrective and preventive actions (CAPA); Mentor junior engineers; Ensure compliance with regulatory standards; Analyze quality data and KPI trends
Seniority
Senior, hands-on IC with leadership scope
