Sr. Quality Engineer - Post-Market Vigilance - Onsite
Core
Lead engineering evaluations of post-market complaints and product performance signals to determine root cause and assess patient/product impact for Neurovascular devices.
Role type
Senior IC quality engineer (post-market vigilance)
Builds
Technically sound risk controls, product improvements, and sustained product reliability for Neurovascular devices
Domain
Medical devices (Neurovascular) + Quality Engineering
Required skills
engineering investigation, root cause analysis, risk management, statistical data analysis, design control, regulatory compliance (FDA/international standards), device design knowledge
Preferred skills
none stated
Technologies
none stated
Responsibilities
Lead engineering evaluations of post-market complaints and product performance signals; Plan and lead complex technical investigations using engineering problem-solving methods; Develop and document technically supported root cause and failure-mechanism conclusions; Partner with cross-functional teams to define containment and corrective actions; Apply design control and risk management principles to evaluate post-market information; Perform complaint trending, signal detection, and data analysis to identify emerging product performance issues
Seniority
Senior, hands-on IC