Quality Assurance Manager im Bereich Q&V
vor 1 Woche
Der Weltmarktführer im Bereich In-vitro-Diagnostik, Roche Diagnostics in Rotkreuz (ZG), sucht Verstärkung im Bereich QA für Qualifizierung und Validierung. Der Kundenkreis umfasst Produktions-, R&D Einheiten sowie auch Post-Market Abteilungen, welche validierte oder qualifizierte Systeme im Bereich der Medizinaltechnik einsetzen.
Quality Assurance Manager im Bereich Q&V (m/w/d)
Deine Aufgaben & Verantwortlichkeiten
In Zusammenarbeit mit den CSV Validierungs-Teams und/oder den Equipment Qualifizierungs-Teams:
- Beratung bei der Erstellung der CSV Validierungspläne und/oder Qualifizierungspläne
- Freigabe der Pläne und Berichte sowie aller weiteren relevanten Dokumenten
- Freigabe von GxP-Changes oder Abweichungen gemäss globalen Prozessen
Ergänzende Aufgaben
- Genaue Impact-Analyse auf lokale Prozesse bei Änderungen im globalen Qualitätsmanagement-System
- Vorbereitung und Abdeckung von QA-Aspekten in ISO 13485 Audits
Dein Profil
- Abgeschlossenes Studium in einem technischen oder naturwissenschaftlichen Bereich
- Min. 3 Jahre CSV Validierungserfahrung im Medtech Bereich (ISO und/oder Erfahrung im Bereich Equipment Qualifizierung/Management und Kalibrierung im Zusammenspiel mit starker Lernfähigkeit
- Sehr gute Deutsch- und Englischkenntnisse sind erforderlich
- Kenntnisse der GSuite und MS Office; SAP-Kenntnisse sind von Vorteil
- Starke Persönlichkeit, die sich argumentativ durchsetzen kann
- Erfahrung im Bereich Qualitätssicherung ist von Vorteil
- Starkes Interesse und/oder Kenntnisse im Bereich Artificial Intelligence sind von Vorteil
Deine Bewerbung
Bitte bewirb dich online. Für weitere Informationen zur Stelle wende dich bitte an deinen Gi-Berater, Nicolas Keller ;
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