Quality Assurance Manager 80
Vor 7 Tagen
- QA End-to-End Verantwortung der Produktplattformen (Entwicklungsprojekte und Product Lifecycle)
- Sicherstellen der Dokumentation und Prozesse für die entsprechende Produktplattform entsprechend den aktuellen Gesetzen, Normen und internen Vorgaben
- Aufrechterhalten und einhalten der internen und Kunden-Qualitätsanforderungen
- Aktive Teilnahme oder koordinieren von Abweichungen, CAPAs und Beanstandungen
- Unterstützen von Produkt-/Prozesstransfers und Change Management Aktivitäten im Rahmen des Product Lifecycles
- Untersuchen von Problemen, die sich auf die Produktqualität auswirken können
- Messen, überwachen und bewerten von Qualitätskennzahlen
- Führen von Aufzeichnungen über Qualitätsberichte, statistische Überprüfungen und relevante Dokumentationen
- Unterstützen bei internen, Kunden- und Behördenaudits
- Mindestens 5 Jahre Berufserfahrung in einer vergleichbaren Rolle im Bereich Medizinprodukte, Pharma oder ähnlich regulierte Industrie
- Ingenieur (Mechanical Engineering) oder naturwissenschaftliche Ausbildung (FH, ETH, Uni)
- Qualifikation und mehrjährige Erfahrung im Umfeld ISO 13485:2016, IEC 62304
- Versierter Umgang mit SAP und Quality Tools (z.B. Trackwise, JIRA)
- Sicheres Auftreten und Vertreten der QA gegenüber B2B-Kunden, Projekt- und Product Lifecycle Teams
- Sehr gute Kommunikationsfähigkeit in Deutsch und Englisch
Ihre Benefits
Pensionskasse
Ypsomed übernimmt 55% der Vorsorgebeiträge
Beitrag zur Mobilität
E-Ladestationen, Halbtax-Abo, Parkplätze, ÖV-Anbindung
Kostenlose Sportanlagen
Schweizweit günstige oder kostenlose Sportangebote
Familienfreundlich
Finanzielle Beteiligung an der Kinderbetreuung
Arbeitszeit-gestaltung
Schichtarbeit, Jahresarbeitszeit, Teilzeit
FlexWork
Arbeiten Sie, wo und wann Sie wollen (in der Schweiz)
Modernste Arbeitsumgebung
Moderne Produktion, Büros und Pausenzonen
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