
Quality Assurance
3 semanas atrás
Cosa ti proponiamo:
All’interno della divisione Public Administration & Healthcare nell’area di mercato/nella Business Line/Coe Healthcare siamo alla ricerca di una figura di Quality Assurance, Testing & Release Advisor.
Avendo competenze su requisiti e standard applicabili andrai ad affiancare i gruppi di sviluppo nella produzione di deliverables finalizzati al completamento del fascicolo tecnico di prodotto.
Andrai a supportare e coordinare attività di analisi su specifiche funzionali volte al completamento dell’analisi dei rischi di prodotto ed eventuali implementazioni di mitigazioni previste.
Avrai un ruolo attivo nella produzione di documentazione propria di release (DHF) e nella formazione all’utilizzo di template standard per il rispetto dei processi.
Garantirai, in collaborazione con il team di prodotto, la sicurezza, l'efficacia e la qualità dei dispositivi medici mediante la corretta applicazione dei principi di gestione del rischio e la piena conformità a tutti i requisiti di gestione della qualità (ISO 13485:2016), normativi (ISO 62304, ISO 62366, ISO 14971) e legislativi applicabili (MDR e IVDR).
Quali saranno le tue attività e responsabilità?
Compiti principali, come supporto al gruppo QARA:
- Garantire la qualità della progettazione (Design Authority), avendo competenze di processo andrebbe ad identificare e correggere disallineamenti rispetto alla procedura aziendale specifica;- Partecipare come membro attivo (quando richiesto) alle riunioni di progetto, validando strategie e affiancando il team di prodotto nella gestione normativa delle singole CR (change request);- Creare e mantenere i principali deliverable normativi legati al ciclo di vita del dispositivo medico;- Gestire la creazione e la manutenzione dei documenti di fascicolo tecnico;- Verificare che tutte le eventuali mitigazioni del rischio dichiarata tra una release ed un’altra siano implementate nel corso del progetto;- Condurre e documentare la pianificazione di rilasci secondo policy aziendale per i nuovi prodotti o per i prodotti esistenti in evoluzione,- Fornire dati KPI ovvero metriche calcolabili per la rendicontazione interna sullo stato del progetto e range di accettazione degli stessi;- Eseguire revisioni/audit sui diversi file di progettazione e sullo stato di applicabilità dei processi;- Esaminare e verificare le NC (non conformità) di prodotto e le CAPA (azioni correttive e preventive) da implementare per garantire il continuo miglioramento del processo;- Verificare i fornitori chiave utilizzati durante la fase di progettazione e riportare la criticità al responsabile per un eventuale valutazione nella documentazione per la ISO 13485 (processo acquisti aziendale);- Esaminare che tutti i test siano esaustivi e completi e identificarne eventuali criticità con proposte di risoluzione.
Qualifiche e competenze richieste:
- Laurea triennale o magistrale in una delle materie attinenti (Ingegneria Biomedica, Ingegneria Clinica, Ingegneria Gestionale, Ingegneria Informatica);- Mentalità analitica e pensiero critico;- Attenzione al dettaglio;- Capacità organizzative e gestionali;- Problem Solving;- Team working.
Cosa cerchiamo nelle nostre persone?- Ambizione, nel perseguire grandi obiettivi e nell'investire sul miglioramento continuo;- Proattività, nell’anticipare e affrontare le sfide con iniziativa;- Trasparenza, nel comunicare apertamente e fornire feedback costruttivi;- Motivazione a migliorare e a crescere insieme agli altri, manifestando apertura al confronto per favorire la crescita collettiva e il raggiungimento degli obiettivi comuni.
SEDE DI INSERIMENTO
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