p>Required Technical and Professional Expertise: Quality System Requirements (QSR), Gage R&R, ISO 13485, IQ/OQ/PQ, CTQ, Production NC, CAPA, Regulatory Requirements, Verification & Validation, Medical devices Engineering change process, Medical Devices Quality Management, Design controls, problem solving skills, etc.
Evaluates the need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc.