Quality Engineer 3 - 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 IC Quality Engineer
Builds
Endoluminal product family (design, manufacturing, service)
Domain
Medical Devices / Robotic Surgery
Required skills
Quality principles and methodologies, Data analysis and interpretation, Independent issue resolution, Regulatory compliance (GMP, ISO, FDA), CAPA management, Risk assessment
Preferred skills
Mentoring junior engineers, Leading small initiatives, Continuous improvement project ownership
Technologies
QMS documentation systems, Data analysis tools
Responsibilities
Own product, process, and complaint investigations; Serve as escalation owner for low to medium impact quality risks; Review and maintain test records; Drive CAPA and process non-conformances; Lead risk assessment activities; Analyze defect trends and report to peers; Ensure compliance with regulatory standards; Contribute to project Core Teams; Communicate findings to stakeholders; Own continuous improvement projects.
