Specialista QRC
4 settimane fa
Descrizione del Ruolo
Il nostro team di Ortho Clinical Diagnostics è alla ricerca di un Specialista QRC per unincarico di alta responsabilità. In questo ruolo, sarai responsabile di garantire che i processi e le strategie normative siano in linea con le normative locali e internazionali, nonché con la visione e la missione di QuidelOrtho.
Compiti e Responsabilità
- Gestire il sistema di gestione della qualità in linea con la strategia di qualità EMEA e gli standard applicabili (ISO 9001, ISO 13485, UNI PdR 125).
- Supportare le revisioni della direzione locale e supervisionare i progetti di miglioramento della qualità.
- Gestire le attività di vigilanza, delle notifiche sui prodotti, dei reclami dei clienti e delle azioni correttive di sicurezza sul campo.
- Collaborare con le funzioni globali di qualità, regolamentazione e conformità, nonché con il rappresentante/produttore del prodotto.
Requisiti del Candidato
- Laurea tecnica in chimica, biochimica, biologia, farmacia, ingegneria.
- Esperienza di 3-5 anni in una posizione simile all'interno di un'azienda del settore (dispositivi medici, IVD o prodotti farmaceutici).
- Ottime capacità di comunicazione e una conoscenza approfondita delle normative italiane e della conformità locale.
- Familiarità con l'ambiente normativo dei dispositivi medici IVD ed esperienza nella gestione dei sistemi di qualità (norme ISO 9001-ISO13485).
- Conoscenza fluente dell'inglese e dell'italiano, sia orale che scritta.
Offerta di Lavoro
Questa è un'opportunità dinamica e stimolante per contribuire al successo del nostro team e garantire i più elevati standard di qualità e conformità normativa.
Noi offriamo un modello di lavoro ibrido, 3 giorni in ufficio e 2 giorni da casa a settimana.
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