Nobel Biocare Quality Engineer (On-Site Yorba Linda, CA)
Core
Ensures quality of processes and products through audits, inspections, tests, defect analysis, and equipment calibration to validate supplier and production quality.
Role type
Quality Engineer (Medical Devices)
Builds
Validated processes and measurement documentation for medical device manufacturing
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulations knowledge, ISO 13485 compliance, defect analysis, trend analysis, statistical techniques (Minitab), project management
Preferred skills
ISO 14791 certification, Six Sigma Greenbelt, project management
Technologies
Microsoft Office Suite, Minitab
Responsibilities
Perform audits, inspections, and tests; conduct defect and trend analysis; program and troubleshoot inspection equipment; calibrate and maintain equipment; report on measurement standards; validate processes; provide documentation from measurement analysis.
Seniority
Mid-level, hands-on IC