Madison, Wisconsin, United States
Quality Control and Medical Device Compliance Specialist with extensive experience in regulated healthcare manufacturing environments. Proven expertise in inspection methodologies, ISO 13485 quality systems, FDA regulatory compliance, and root cause analysis. Skilled in defect identification, corrective and preventive action (CAPA) implementation, and continuous process improvement. Recognized for analytical precision, audit readiness, and maintaining strict adherence to quality and documentation standards in clinical device production settings.