Experience

MQA Certification UK Ltd.

• United Kingdom
• Business Consulting and Services
• 1 - 100 Employee

• ISO lead auditor

  • May 2022 - Present

  As an Empaneled Lead Auditor I am authorized to conduct audit for the following management systems: - ISO 9001 Quality Management System - ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes As an Empaneled Lead Auditor I am authorized to conduct audit for the following management systems: - ISO 9001 Quality Management System - ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes



Freelance

• Medical device auditor

  • Jun 2010 - Present

  Auditor, as a freelancer, on behalf of Notified Bodies, conducting inspection and verification of technical files and Quality Management System to ensure that manufacturers products meet applicable requirements and specifications (93/42/EEC, UNI EN ISO 9001:2008 and UNI EN ISO 13485:2012). Auditor, as a freelancer, on behalf of Notified Bodies, conducting inspection and verification of technical files and Quality Management System to ensure that manufacturers products meet applicable requirements and specifications (93/42/EEC, UNI EN ISO 9001:2008 and UNI EN ISO 13485:2012).



Istituto Superiore della Sanità

• Medical devices auditor

  • Mar 2013 - Apr 2015

  Assessment, control and verification, on behalf of Competent Autority, in the area of medical devices in order to ensure the proper application of the provisions of MDD directive and to verify the correct implementation of the quality management system. Assessment, control and verification, on behalf of Competent Autority, in the area of medical devices in order to ensure the proper application of the provisions of MDD directive and to verify the correct implementation of the quality management system.



Italian Ministry of Health

• Medical Devices expert

  • Jan 2008 - May 2010

  Assessment, control and verification in the area of medical devices in order to ensure the proper application of the provisions of MDD and IVD directives and to verify the correct implementation of the quality management system. Assessment, control and verification in the area of medical devices in order to ensure the proper application of the provisions of MDD and IVD directives and to verify the correct implementation of the quality management system.



Italian National Institute of Health

• Auditor/Lead auditor

  • Nov 2002 - Dec 2007

  Assessment, control and verification in the area of medical devices in order to ensure the proper application of the provisions of MDD directive and to verify the correct implementation of the quality management system. Technical and scientific support to the Italian Ministry of Health in assessment of the clinical safety and performance of medical devices intended for clinical investigations Assessment, control and verification in the area of medical devices in order to ensure the proper application of the provisions of MDD directive and to verify the correct implementation of the quality management system. Technical and scientific support to the Italian Ministry of Health in assessment of the clinical safety and performance of medical devices intended for clinical investigations