Quality Engineer II
Core
Hands-on quality professional supporting manufacturing and post-manufacturing activities to ensure safe, effective, and compliant medical devices.
Role type
Quality Engineer II
Builds
Medical devices for orthopedic, neuro, thoracic, and spine surgeries
Domain
Medical device manufacturing (orthopedic, neuro, thoracic, spine)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485, FDA QMSR, GMP/GDP, Design Controls, root cause analysis, risk management (ISO 14971), statistical process control (SPC), failure analysis, measurement system analysis, process validation, supplier quality management, data visualization
Preferred skills
Minitab, Excel, dashboards or data visualization tools
Technologies
Excel, Minitab
Responsibilities
Manage complaint investigations, CAPAs, and nonconformances; lead or support root cause investigations and failure analysis; support process validation activities including protocol development and measurement system analysis; analyze manufacturing and quality data to identify trends and improvement opportunities; review engineering and supplier changes for quality impact; develop and maintain quality metrics and reports
Seniority
Mid-level, hands-on IC