Quality Engineer
Core
Define quality metrics and specifications, lead quality improvement initiatives, and act as a technical consultant for complex robotics and optics quality challenges.
Role type
Senior Quality Engineer (Medical Robotics & Optics)
Builds
Medical robotic products and manufacturing processes
Domain
Medical devices, Robotics, Optics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality management systems (QMS), Regulatory compliance (CFR 21 820/ISO 13485), Risk management (FMEA), Design for X (DFX), Statistical Process Control (SPC), Six Sigma (DMAIC), Data analysis (Excel), Protocol development, Validation and verification planning
Preferred skills
Advanced degree in Engineering, Experience in medical device design, Cross-functional leadership
Technologies
Excel, QMS tools, FMEA software
Responsibilities
Develop measurable quality goals, define critical design elements, ensure regulatory compliance, analyze non-conformances and technical failures, support production processes and line qualification, lead quality improvement initiatives, conduct audits and Gemba walks, mentor engineering staff on quality best practices
Seniority
Senior, hands-on IC with leadership responsibilities
