Design Change
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ricerca per azienda cliente leader nello sviluppo e produzione di dispositivi medicali ad alta tecnologia:
1 - DESIGN CHANGE & CONTROL SPECIALIST â SETTORE ELETTROMEDICALE
La risorsa sarà inserita allâ interno dellâ area Ricerca & Sviluppo e si occuperà della gestione del processo di change control e della revisione della documentazione tecnica di progetto relativa a dispositivi medici.
Attività principali:
Gestione del processo di modifica prodotto (change control)
Revisione delle proposte di modifica e valutazione dellâ impatto tecnico e regolatorio
Revisione della documentazione tecnica di progetto secondo i requisiti ISO 13485
Preparazione documentazione necessaria per audit e ispezioni di enti terzi
Gestione e aggiornamento del Fascicolo Tecnico e del Design History File (DHF)
Requisiti richiesti:
Diploma ITS o Laurea triennale in Ingegneria Biomedica o discipline affini
Esperienza di circa 3 anni in ambito Regulatory Affairs, Quality Assurance, Design Control o Change Control nel settore dei dispositivi medici
Conoscenza della normativa ISO 13485 e del Regolamento MDR 2017/745
Conoscenza delle metodologie di gestione del rischio secondo ISO 14971
Buona conoscenza della lingua inglese
Sede di lavoro: CALENZANO (FI)
Inquadramento:
CCNL Metalmeccanico Industria
RAL indicativa: 30.000â ¬ â 45.000â ¬
Mensa aziendale e palestra aziendale gratuite
#PRIOBOL
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