Quality Assurance Manager Medicale
hace 4 semanas
Categoria: Healthcare / Pharmaceutical
Luogo di lavoro: Milano e provincia
Page Group seleziona un Quality Assurance Manager per azienda medicale.
- Provvedere all'aggiornamento della normativa interna del "sistema qualità" (manuale della qualità, procedure, istruzioni operative e moduli), in coerenza con le procedure interne e la normativa vigente.
- Garantire la conformità dei prodotti dell'azienda alle normative e ai requisiti di qualità richiesti dal mercato, attraverso la pianificazione, l'organizzazione e il controllo dei processi produttivi.
- Assicurarsi che l'azienda rispetti gli standard di qualità richiesti dai clienti, dalle normative e dalle certificazioni.
- Preparare audit annuali per certificazione ISO 13485.
- Preparare audit presso i fornitori, compresa la pianificazione, la preparazione, l'esecuzione, la comunicazione dei risultati e i piani di lavoro correttivi.
- Garantire che gli obiettivi di qualità dei prodotti e dei processi siano conformi agli standard e alle politiche di qualità aziendali.
- Coordinare i processi di certificazione del prodotto (CE).
- Garantire il livello qualitativo della produzione attraverso KPI specifici e il controllo dei prodotti finiti.
- Coordinamento con Global HSQE gruppo.
- Coordinare la gestione delle deviazioni e delle non conformità di processo e di prodotto, assicurando pianificazione ed esecuzione delle azioni correttive e preventive (CAPA).
- Gestire le indagini e la risoluzione dei reclami dei clienti.
- Gestire i rapporti con i fornitori per quanto riguarda gli aspetti qualitativi, garantendo lo standard qualitativo dei materiali in entrata e la conformità del fornitore agli standard aziendali.
- Forte interazione e collaborazione con gli altri reparti aziendali, quali R&D, Produzione, Acquisti.
- Supervisionare il controllo qualità tramite laboratorio.
- Continua formazione sul personale (anche di produzione) e aggiornamento professionale.
- Coordinamento e confronto con il consulente in ambito regolatorio.
Requisiti: Capacità e competenze richieste: Laurea in un campo scientifico o tecnologico. Preferibile laurea specialistica. 5+ anni di esperienza nell'Assicurazione Qualità, in ruoli di responsabilità. Ottima conoscenza della lingua inglese (minimo C1). Utilizzo avanzato di Office. Conoscenza delle tecniche di gestione della qualità e delle normative sulla qualità. Esperienza di lavoro con enti esterni, come laboratori di certificazione e fornitori, su temi di qualità e certificazione. Problem solving e mentalità analitica. Capacità di lavorare in gruppo, leadership e gestione delle relazioni. Domicilio su Milano o limitrofi. La risorsa sarà l'unica ad occuparsi della qualità.
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