Quality Engineer - Endoluminal Systems
Core
Independently owns quality projects, investigations, inspections, and improvement activities for the Endoluminal product platform spanning design, manufacturing, and service.
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
product and process investigations, CAPA management, risk assessment, data analysis, QMS documentation, regulatory compliance (GMP, ISO, FDA), continuous improvement
Preferred skills
mentoring junior QEs, leading small initiatives
Technologies
QMS tools, inspection tools
Responsibilities
Own product, process, and complaint investigations; review and maintain test records; drive CAPA and systemic process non-conformances; lead risk assessment activities; analyze defect trends; ensure compliance with regulatory standards; contribute to project Core Teams
Seniority
Senior, hands-on IC with mentorship capabilities
