Note: LinkedIn is a tool that I use to follow people, organizations, etc., that share relevant information akin to my professional field(s) of interest, and as a platform to stay in touch with dear (ex) colleagues. Hence, my shared personal information is quite limited. Product reviewer, Lead assessor QMS - Active Devices and Software (SiMD & SaMD): MDT 2001, MDT 2002, MDT 2007, MDT 2008, MDT 2010, MDT 2011, MDT 2001, MDS 1001, MDS 1006, MDS 1009, MDS 1010, MDA 0203, MDA 0204, MDA 0302, MDA 0305, MDA 0306, MDA 0307, MDA 0308, MDA 0309, MDA 0310, MDA 0311, MDA 0315, MDN 1103, MDN 1213, MDN 1204, MDN 1205, and MDN 1209.• Experienced Quality Auditor and Quality Engineer at Original Equipment Manufacturer (OEM) and Medical Device companies.• Experience working at Notified Bodies (NB), multiple codes related to plastics, metal, pharma, software, electronics.• Experience working at Certification Body and Nationally Recognized Testing Laboratories (CBTL and NRTL)• Certified Auditor of Quality Management Systems ISO 13485:2016/2003• Certified Auditor of Quality Management Systems ISO 9001:2015/2008• Reviewer of Risk Management File, per process standard ISO 14971 2019/2012/2007• Reviewer of Usability File, per IEC 62366 and IEC 60601-1-6• Reviewer IEC 62304, IEC 82304-1• Experience with GSPR relevant Medical Device Safety Standards.• Experience with Calibration and Preventive Maintenance.• Experience with personnel training.INTERNATIONAL WORK EXPERIENCE: Lived, worked, paid taxes in the following countries.Europe (Switzerland, Germany, Spain) and North-America (Canada and U.S.)LANGUAGES:English: Full professional working proficiency. Spanish: Full professional working proficiency.Italian: Limited working proficiency (Competence to review Technical Documentation and Reports).French: Limited working proficiency (Competence to review Technical Documentation and Reports).