Experience

Certiquality Srl

• Italy
• Environmental Services
• 1 - 100 Employee

• Medical Device Certification Specialist

  • Sep 2020 - Present

  Project leader for the product certification process according to the MDR 2017/745. Main activity is the coordination of several evaluations performed on the Technical File of the medical device: -technical evaluation to verify the compliance to the MDD 93/42/EEC and MDR 2017/745 -reporting of the outcomes regarding technical and clinical evaluations -business relationship with the customers and technical/clinical experts -professional updates and continuous training Project leader for the product certification process according to the MDR 2017/745. Main activity is the coordination of several evaluations performed on the Technical File of the medical device: -technical evaluation to verify the compliance to the MDD 93/42/EEC and MDR 2017/745 -reporting of the outcomes regarding technical and clinical evaluations -business relationship with the customers and technical/clinical experts -professional updates and continuous training



Adler Ortho Spa

• Medical Equipment Manufacturing
• 1 - 100 Employee

• • Oct 2017 - Sep 2020

  Gestione operativa delle attività di controllo con la collaborazione di un team dedicato, garantendo un continuo monitoraggio del sistema al fine di assicurare la conformità agli standard ISO 9001 e ISO 13485 e mantenerne la certificazione.- Supervisione del processo produttivo: controllo qualità in linea (nelle differenti fasi di lavorazione, incluse quelle specifiche per la tecnologia Additive Manufacturing), di post-produzione (controllo finale) e di approvvigionamento. Controllo qualitativo e quantitativo dei semilavorati e dei prodotti finiti, ispezione delle caratteristiche dei materiali acquistati o prodotti in conto terzi, verifica della correttezza delle schede tecniche.- Redazione delle Performance Qualification (PQ) di macchine produttive in fase di post installazione- Gestione delle non conformità di prodotto/semilavorato/processo.- Ispezione e validazione dei fornitori in modo da assicurare la conformità dei prodotti in ricezione.- Definizione di piani di controllo per nuovi prodotti e/o nuovi fornitori- Utilizzo e programmazione di macchine di misura quali Zeiss Contura, FARO Edge e microscopio a scansione elettronica Zeiss EVO, Bruker detector per analisi EDX.- Analisi periodica dei dati oggetto di registrazione (Non Conformità di prodotto) al fine di ottenere degli andamenti che riescano a monitorare nel tempo le prestazioni delle macchine, dei processi, dei fornitori.- Presentazione dei dati statistici (relazioni e/o presentazioni orali) ai collaboratori così come alla Direzione- Impiego di strumenti propri del Lean Managment (6 sigma-FMEA-Pareto-5S) e di statistica applicata (process capability, smpling, Design of Experiement) Show less

• • Oct 2014 - Oct 2017

  Active role in the quality control activity leading a dedicated team and ensuring the compliance system in according to ISO 9001 and ISO 13485 standards through a continuous process monitoring.• Supervision of the production system of orthopedic implant and surgical instruments (with a focus on additive manufacturing technology): systematic process of control to verify the product compliance to the specified requirements. Quality control of raw materials, assemblies, components, final and semi-finished products.• Performance Qualification (PQ) protocol editing on equipments installed• Non-conformity management by Non-Conforming Material Reports (NCMRs)• Incoming inspection: checking of purchase products and vendor validation. Programming and controlling of CMM Zeiss instrumentation, laser scanner FARO Edge by ControlX software, SEM/EDX analysis by Zeiss/Bruker instrumentation. Diffraction analysis by dedicated tools (X-ray source) to investigate the material properties after treatments.• FEM analysis by Ansys Workbench on prototype implants• Instrument management and calibration tests• Management of technical dossiers and certificates through internal quality system dataset and storage activity Show less



Istituto Ortopedico Rizzoli - Laboratorio di Tecnologia Medica

• Italy
• Research Services
• 1 - 100 Employee

• Researcher

  • Sep 2011 - Sep 2014

  • Patient- specific FE modeling of bone starting from CT images • Validation of the numerical models • FE analysis to evaluate bone tissue strength at the organ level (vertebrae and femurs) • Development of probabilistic hypermodel of the proximal femur to predict the risk of fracture (European project) • Test user of innovative technologies for the generation of virtual femoral anatomies in order to do population studies • Activities of reverse engineering • Patient- specific FE modeling of bone starting from CT images • Validation of the numerical models • FE analysis to evaluate bone tissue strength at the organ level (vertebrae and femurs) • Development of probabilistic hypermodel of the proximal femur to predict the risk of fracture (European project) • Test user of innovative technologies for the generation of virtual femoral anatomies in order to do population studies • Activities of reverse engineering



IRCCS Istituto Ortopedico Rizzoli

• Hospitals and Health Care
• 500 - 600 Employee

• Biomedical Engineer, Intern

  • May 2011 - Jun 2011

  Stage RITMO (Research and Technological Innovation in Orthopedic Medicine) in Istituto Ortopedico Rizzoli, Bologna: lessons about Biotribology (wear analysis of joints replacements and clinical tribology), Medical Physics (applied Research on diagnostic methods, efficacy studies on new technologies, telematics in medicine), Computational Biomechanics (computer models of the musculoskeletal apparatus, computer aided medicine), Functional Biomechanics (stress and strain analysis, mechanical properties of whole organs), Biomaterials (biomechanical properties of tissues), Project Management Office (manage all research grants, project management and dissemination). Show less