Federico
Technical and Regulatory Support Specialist Europe @TÜV SÜD
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WORK HISTORY
Technical and Regulatory Support Specialist Europe @TÜV SÜD
Casalecchio di Reno, IT
Onboarding of new clients in Europe Global Team for certification requests.Support to Operation team for special certification projects on existing clients.
EDUCATION
ITIS "G. Marconi" Verona
High School Diploma, IT, Computer Programmer
Università degli Studi di Trieste
Master's degree, Clinical Engineering
Università degli Studi di Padova
Bachelor's degree, Biomedical Engineering
SKILLS
ABOUT FEDERICO
I am a Clinical-Biomedical Engineer with experience in biomedical devices acquired during internship in different Italian hospitals, two years as Field Service Engineer in Verona and Brescia hospitals, four years as Quality Engineer in Orthofix Srl and since 2021 as Auditor, Lead Auditor, Technical Documentation Assessor and Customer Specialist - Non-Active Implantable and Active Non-Implantable Medical Devices in TUEV SUD MHS Department. My skills are releted to the following processes- Problem Solving and Root Cause Analysis- Key Performance Indicators calculation and process monitoring- Corrective and Preventive Actions- Oversign and management of NC- Design Of Experiments and related tests- Statistical Data Analysis- Lead and participate in the development and improvement of the manufacturing processes for existing and new products- Analysis and review of concession requests- First Article Inspection- Internal and External Audit- Risk Management practicles and tools- Lean and Kaizen principles- Lead Auditor ISO 13485, ISO 9001, MDR, MDD, MDSAP- Technical Assessor. ACADEMIC QUALIFICATION- Master’s Degree in Clinical-Biomedical Engineering, University of Trieste, 20••••14- Bachelor’s Degree in Biomedical Engineering, University of Padua, 20••••11- Certificate of Computer Programmer, ITIS “G. Marconi”, Verona, 2007.SOFTWARE SKILLSJava, HTML, C++, Visual Basic, PHP, PL/SQL, MatLab/ Simulink, HL7, SQL, R, MINITAB;Tools: Eclipse, JBuilder, IE;DMS: Oracle, SQL Server;Office: Word, Excel, Power Point, Access;
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