Senior Engineer, Advanced Quality (Onsite)
Core
Lead design quality activities for neurosurgical instruments throughout new product development, ensuring compliance with FDA and ISO 13485 requirements.
Role type
Senior IC quality engineer (medical devices)
Builds
Neurosurgical instruments
Domain
Medical devices / Regulatory quality
Required skills
risk management, reliability engineering, human factors engineering, design verification and validation, process validation, statistical methods, root cause analysis, FDA Quality System compliance, ISO 13485 compliance
Preferred skills
Advanced Quality Engineering, Design Quality Engineering, Good Manufacturing Practice, Good Documentation Practice, Geometric Dimensioning and Tolerancing (GD&T)
Technologies
FDA Quality System, ISO 13485, Six Sigma, GD&T
Responsibilities
Lead product risk management activities including failure mode evaluation and risk mitigation; Develop reliability testing strategies and accelerated test methods; Support design verification, process validation, and manufacturing process development; Partner with cross-functional teams to review technical deliverables and resolve quality issues; Support nonconformance and corrective and preventive action investigations.
Seniority
Senior, hands-on IC