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Open nowFirst seen 5 days ago

Tecnico Qualità / Regolatorio Dispositivi Medici

Clutch99 open roles

Where
Forli, Province of Forlì-Cesena, Italy
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Your applicationOpen nowTecnico Qualità / Regolatorio Dispositivi MediciClutch · Forli, Province of Forlì-Cesena, Italy

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. Clutch postings stay open a median of 1 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

Clutch median: 1 days open

The posting

Il nostro cliente è una PMI innovativa, un'azienda produttrice di dispositivi biomedicali concepita a Londra e fondata in Italia nel 2014. Guidata da un team con oltre dieci anni di esperienza nella progettazione di dispositivi medici, l'azienda ha raccolto finora più di 1 milione di euro in finanziamenti provenienti da investitori.

Ricerchiamo un Tecnico Qualità / Regolatorio Dispositivi Medici (ambito elettromedicale).

Principali mansioni:

  • Gestione della qualifica e del monitoraggio dei fornitori, incluse le attività di redazione e aggiornamento dei Quality Agreement, non conformità e audit, quando previsti
  • Controlli qualità (Quality Check) in accettazione, produzione e collaudo
  • Gestione delle non conformità interne e monitoraggio dei trend
  • Supporto al Responsabile Qualità nelle seguenti attività:Monitoraggio degli aggiornamenti normativi Aggiornamento e revisione delle procedure operative, quando necessario Aggiornamento dei Fascicoli Tecnici dei prodotti in caso di modifiche Vigilare sulla corretta applicazione delle procedure del Sistema Qualità

Competenze richieste:

  • Conoscenza norma ISO 13485 e Regolamento MDR 745/2017 ed in particolare la gestione del Sistema Qualità e del fascicolo tecnico
  • Conoscenza della IEC 60601-1 (sicurezza elettrica dei dispositivi medici) sarà considerata un plus
  • Conoscenza delle procedure di registrazione dei dispositivi medici sarà considerata un plus
  • 1-2 anni di esperienza in ambito Qualità/Affari Regolatori, preferibilmente nel settore dei dispositivi medici

Competenze soft:

  • Capacità gestionali e organizzative
  • Capacità a lavorare in gruppo e a collaborare per il raggiungimento comune di obiettivi
  • Problem solving

Location: Forlì

Contratto a tempo indeterminato RAL 30K - 32K

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