Senior (Quality Engineer 4) - 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 (IC)
Builds
Endoluminal product family quality outcomes and compliance
Domain
Medical Devices / Robotic Surgery
Required skills
Quality investigations, CAPA management, risk assessment, regulatory compliance (GMP/ISO/FDA), data analysis, NPI support, mechanical assembly knowledge, cross-functional leadership
Preferred skills
Mentorship, stakeholder influence, continuous improvement project ownership
Technologies
None explicitly listed
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 and technicians; Ensure compliance with regulatory standards; Analyze quality data and KPI trends
Seniority
Senior, hands-on IC with leadership scope
