Lab Quality Engineer (Atlanta, GA, or other unanticipated locations throughout U.S.)
Core
Ensuring quality and compliance of laboratory processes, equipment, and deliverables for orthopedic testing and surgical devices.
Role type
Quality Engineer (Medical Devices)
Builds
Validated test methods, equipment qualifications, and compliant laboratory processes for orthopedic implants and surgical devices.
Domain
Medical Devices / Orthopedics / Quality Assurance
Required skills
Risk Management, DFMEA/PFMEA, Root Cause Analysis, CAPA Management, Regulatory Compliance (21 CFR Part 11, ISO 17025), Change Control, Document Management, Statistical Analysis, Equipment Qualification, GxP Testing
Preferred skills
ASTM/ISO standards knowledge, Audit & Inspection Readiness, Post-Market Failure Mode Evaluation
Technologies
Windchill PLM, Filtrex, Scanning electron microscopic software, torque drivers, load frames, optical microscopes
Responsibilities
Validate laboratory equipment and software for orthopedic testing; Conduct torsional, functional, and fatigue testing of implants; Investigate non-conformances and implement CAPA; Review and approve controlled documents and test methods; Perform calibration gap assessments and equipment qualification; Ensure compliance with regulatory guidelines and ISO 17025.
Seniority
Mid-level Engineer