Quality Engineer - Orthopedics
Core
Setting quality standards, validating processes, and managing supplier quality for orthopedic medical devices.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes and regulatory compliance documentation for orthopedic devices
Domain
Medical Devices / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control (SPC), experimental design, CAPA management, regulatory compliance (21 CFR 820, ISO13485), supplier qualification, risk management
Preferred skills
Medical device industry experience, advanced Excel skills
Technologies
MS Office Suite, statistical analysis tools
Responsibilities
Manage process control and validation methods, design experiments to analyze variation, lead supplier quality programs, build Device Master Records, coordinate product testing, lead non-conformance investigations
Seniority
Mid-level, hands-on IC