Quality Engineer

Vor 4 Tagen

Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit
Entwicklung.
Ypsomade. Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Burgdorf im Production Management Team eine kundenorientierte und qualitätsbewusste Persönlichkeit als

Quality Engineer | - %

Ref-Nr. 2 Arbeitsort: Burgdorf | Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu bringen, indem Sie dank Ihrer strukturierten Herangehensweise Prozesse optimieren und die Qualität sicherstellen.

Ihre Hauptaufgaben

Sicherstellen, dass die Qualitätsanforderungen an die Produkte, Abläufe und Dokumentation im Verantwortungsbereich eingehalten werden Sicherstellen, dass die Produkte gemäss den aktuellen Richtlinien, Vorgaben und Normen wie beispielsweise cGMP, ISO , CFR Part und FDA Guidelines hergestellt werden QA-Ansprechpartner am Standort Prüfen und Freigeben der Herstelldokumente Arbeitsanweisungen, Batch Release Fertigerzeugnisse, «decision of use») Prüfen und Freigeben der Dokumente im Rahmen der Qualifizierungs- und Validierungstätigkeiten DQ, IQ, OQ, PQ) Prüfen, Freigeben und Abschliessen von Änderungen und der dazugehörigen Dokumente im Verantwortungsbereich (Change Control) Bearbeiten NC/CAPAs gemäss Abweichungsmanagement Klassifizierung, Freigabe Massnahmen, Prüfung und Abschluss) Mitarbeit bei internen, Kunden-, Behörden- und Lieferantenaudits Selbstständiges Arbeiten in multidisziplinären Teams

Ihr Profil

Abgeschlossene technische oder naturwissenschaftliche Ausbildung (HF, FH oder vergleichbar) Weiterbildung im Bereich Qualitätswesen Vertiefte Kenntnisse im Bereich Qualitätssicherung/cGMP Erfahrung in einer vergleichbaren Rolle im Bereich MedTech oder Pharma Versierter Umgang mit SAP und Quality Tools FMEA, SPC usw.) Sehr gute Kommunikationsfähigkeiten in Deutsch und Englisch Eigeninitiativ und dienstleistungsorientiert Erfahren in risikobasierter Entscheidungsfindung Erfahren im Bereich Spritzguss, Montage und/oder Smart Devices von Vorteil

Ihre Benefits

Arbeitszeit-gestaltung

Schichtarbeit, Jahresarbeitszeit, Teilzeit

FlexWork

Arbeiten Sie, wo und wann Sie wollen (in der Schweiz)

Modernste Arbeitsumgebung

Moderne Produktion, Büros und Pausenzonen

Pensionskasse

Ypsomed übernimmt % 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

Pensionskasse

Ypsomed übernimmt % 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 Ihre Ypsomed-Arbeitswelt { "name": "Ypsomed Company Movie EN", "description": "Ypsomed Company Movie EN", "thumbnailUrl": "uploadDate": "4--T::.+0", "contentUrl": "duration": "@context": "@type": "VideoObject" }

Darum Ypsomed – die Behandlung von chronischen Erkrankungen möglich machen

Die weltweit über 0 Mitarbeitenden der Ypsomed Gruppe entwickeln und produzieren Injektions- und Infusionssysteme für die Selbstmedikation. Wir sind ein erfolgreiches, rasch wachsendes, familiengeführtes Unternehmen mit Hauptsitz in Burgdorf (CH) und weltweit verschiedenen Produktionsstandorten und Tochtergesellschaften. Mit unseren marktführenden Produkten und Lösungen ermöglichen wir Menschen auf der ganzen Welt die Selbstbehandlung. Trotz chronischen Erkrankungen wie Diabetes, Fettleibigkeit oder gewissen Arten von Krebs erhalten sie damit grösstmögliche Freiheit.

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