Quality Manager

2 mesi fa


Como, Italia E.Janach S.r.l. A tempo pieno

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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