25+ years Quality Assurance in Medical device and Pharmaceutical companies. Certified lead auditor by Exemplar Global. Extensive experience as lead auditor of QMS/GMP/GCP and broad technological process globally. Successful implementation of quality and regulation such as ISO 9001, FDA 21 CFR 820/210/211/11, ISO 13485, ISO 14971, ISO 14001, ISO 14155, ISO 27001, GDPR, and more. Leading continuous improvements plans (CAPA) towards operational excellence. In depth involvement with multi