Quality Manager
2 mesi fa
E.Janach Srl produce e commercializza strumenti per la chirurgia oftalmica. Si ricerca una figura che sia responsabile per il mantenimento del sistema gestione qualità in conformità agli standard ISO 13485 e ISO 9001 e che collabori sul fronte regolatorio alla produzione della documentazione técnica necessaria al mantenimento della certificazione CE secondo MDD e per la transizione al nuovo regolamento MDR.
Mansioni principali:
Mantenimento del sistema gestione qualità
Gestione dei reclami
Comunicazione con enti notificati e autorità competenti per adempiere ai requisiti di vigilanza
Gestione del rischio in accordo a ISO 14971
Comunicazione con la direzione per aggiornamento avanzamento obiettivi aziendali, discussione rischi e opportunità, riesame della direzione
Coordinamento delle attività di PMS e PMCF, raccolta dati dalla letteratura e da database su incidenti e reclami, analisi dei relativi dati raccolti e preparazione dei report
Audit interni sui processi condotti dalle altre figure aziendali
Audit esterni
Gestione dei fornitori
Preparazione documentazione per registrazione e mantenimento registrazione dei dispositivi in paesi extra UE
Aggiornamento della documentazione técnica per adeguamento a nuovo regolamento MDR
Preparazione agli audit degli enti notificati sul sistema gestione e certificato CE
Corrispondenza con colleghi, fornitori, clienti, distributori per questioni di natura regolatoria
Gestione delle non conformità
Gestione azioni correttive/preventive
Competenze richieste:
Buone capacità comunicative
Buona conoscenza della lingua inglese
Capacità organizzative (identificazione dei tasks a partire da un obbiettivo, affidare delle priorità, previsione tempistiche entro cui si svolgeranno i tasks, svolgimento entro i termini prestabiliti)
Conoscenza ISO 13485
Conoscenza MDR
Buona conoscenza dei principali tools di Office
Resilienza e determinazione al raggiungimento degli obiettivi
Contratto di lavoro: Tempo pieno, Tempo indeterminato
Stipendio: €1.400,00 - €1.800,00 al mese
Orario:
- Dal lunedì al venerdì
Tipi di retribuzione supplementare:
- Quattordicesima
- Tredicesima
Esperienza:
- Gestione della qualità: 2 anni (Obbligatorio)
Lingua:
- Inglese (Obbligatorio)
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