Lavori attuali relativi a Quality and Regulatory Manager Settore Medicale - Bergamo, Lombardia - AXL Spa - Agenzia per il lavoro
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Quality and Regulatory Manager Settore Medicale
3 mesi fa
**Quality and Regulatory Manager**
Obiettivo dell'inserimento è la gestione ed il miglioramento del sistema qualità volontario implementato per supportare le strategie aziendali, oltre al mantenimento ed aggiornamento della compliance aziendale agli aspetti regolatori nazionali ed internazionali.
Riportando all'Operation Manager, coordina quattro risorse che operano in area qualità e collabora trasversalmente con tutti i reparti aziendali.
Attività e responsabilità:
- Gestisce e garantisce il mantenimento aggiornato del sistema di qualità volontario implementato in azienda (EN ISO 9001 e EN ISO 13485 e la rispondenza alla regolamentazione europea sui Dispositivi Medici in Vitro Diagnostica EU 746/2017
- Revisiona, migliora ed aggiorna, in collaborazione con gli altri enti coinvolti, l'efficacia dell'architettura del sistema di controllo qualità (documentazioni quali procedure, istruzioni, piani di controllo, etc) sui materiali in ingresso per la filiera produttiva (materie prime e wip) e sui prodotti finiti (collaudo finale)
- Supporta le attività di controllo nei processi produttivi svolte dal personale appartenente ai vari reparti aziendali per assicurare che i prodotti finiti rispettino gli standard richiesti
- Gestisce, in collaborazione con gli altri enti coinvolti, le eventuali segnalazioni ricevute degli organi di vigilanza nazionali o internazionali, i claim dei clienti, le non conformità interne e quelle esterne dei fornitori
- Supervisiona le azioni correttive implementate
- Valuta in collaborazione con i buyers le performance dei fornitori
- Redige per il board aziendale la reportistica di qualità in merito alle performance aziendali attraverso i kpi qualitativi identificati,
- Pianifica e gestisce gli Audit interni ed esterni
- Svolge attività formativa e di aggiornamento a tutti gli attori aziendali in merito agli aspetti regolatori
- Supporta, per gli ambiti di pertinenza, i progetti di sviluppo nuovi prodotti (dal concept al follow up post vendita)
- Concorda con l'area técnica R&D e l'area acquisti le specifiche di controllo delle MP, WIP e PF interne ed esterne
- Collabora alla revisione delle specifiche di prodotto e all'aggiornamento dei fascicoli tecnici per le attività di competenza
- Supporta attività di test interni, prove di controllo e di ricerca, per nuovi prodotti o modifiche di prodotti esistenti
Si richiede:
- Indispensabile provenienza dal settore dei dispositivi medici per la diagnostica (necessaria approfondita conoscenza del Regolamento UE 746/2017)
- Esperienza lavorativa maturata nell'area qualità di aziende manifatturiere strutturate e certificate ISO
- Esperienza nella gestione e coordinamento di collaboratori
- La conoscenza dei gestionale SAP è un plus
- Inglese fluente
Si offre:
- assunzione diretta da parte del nostro cliente con inquadramento e retribuzione in linea con l'esperienza effettivamente maturata
- ambiente di lavoro attento alle esigenze dei dipendenti, solido, stabile e in continua espansione
- prospettive di crescita professionale
Luogo di Lavoro: Provincia di Bergamo
