Qa/Ra Specialist

2 giorni fa


Segrate, Italia Zimmer Biomet A tempo pieno

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
What You Can ExpectSupportare le attività QA/RA quotidiane e su progetti stabiliti
- How You'll Create ImpactGestione della azioni correttive sul campo
- Gestione delle registrazioni di dispositivi medici nel repertorio
- Predisposizione delle schede tecniche di prodotto
- Gestione di audit interni e audit esterni (NB)
- Gestione del processo di non conformità per la ricerca della root cause e soluzioni
- Creare statistiche mensili dalle raccolta dei dati
- Coordinare le attività delle Azioni Correttive e Preventive CAPA (Coordinatore CAPA)
- Fornire supporto agli uffici gare o di customer service nella raccolta delle informazioni richieste
dai produttori
- Sviluppare e revisionare procedure interne
- Registrare i reclami nel database
- Gestione di progetti interdisciplinari locali / EMEA
- What Makes You Stand OutEsperienza nel settore medicale 2-4 anni
- Conoscenza della direttiva dispositivi medici e del Regolamento Dispositivi Medici
- Conoscenza delle ISO 13485 / GDP
- Gestione di audit interni ed esterni (certificato costituisce titolo preferenziale)
- Capacità d'interazione con enti di certificazione e autorità competen
Conoscenza di analisi statistica
- Ottima conoscenza della lingua inglese
- Ottima conoscenza del pacchetto Office, in particolare Excel Power Point, PowerBI e SAP.
- Capacità di creare buone relazioni con i colleghi e gestire un piccole team
- Capacità di definire priorità e rispettare e fare rispettare le tempistiche
- Travel ExpectationsEOE/M/F/Vet/Disability


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