Quality Assurance Officer
vor 1 Monat
- Beaufsichtigt die täglichen qualitätsrelevanten Abläufe des Labors und stellt die Nachhaltigkeit sowie Effektivität des Managementsystems sicher.
- Stellt die Einhaltung von Standardarbeitsanweisungen, Unternehmensrichtlinien und behördlichen Anforderungen sicher.
- Arbeitet mit Abteilungsleitern zusammen, um neue Verfahren zu implementieren und zu dokumentieren.
- Überwacht und pflegt das Dokumentenmanagementsystem, einschließlich Prüfung, Ablage und Archivierung von Daten.
- Unterstützt und berät Labore bei der Umsetzung des Managementsystems im Einklang mit behördlichen und Akkreditierungsanforderungen.
- Entwickelt und verbessert kontinuierlich das Qualitätsmanagementsystem und führt Schulungen zu Qualitätsrichtlinien und -verfahren durch.
- Analysiert Daten, verfolgt Probleme und Trends zur Identifizierung von Prozess- und Schulungslücken und hilft bei der Entwicklung von Lösungen.
- Überwacht qualitätsrelevante Themen, wie Nichtkonformität, Korrektur- und Vorbeugemassnahmen, Änderungsmanagement und unterstützt Endbenutzer.
- Informiert den Qualitätsmanager über qualitätsbeeinträchtigende Probleme und Ergebnisse von Audits, Validierungen sowie Massnahmen.
- Sammelt Informationen für die jährliche Managementbewertung (AMR), verfolgt Projekte und Ziele und verwaltet die Indikatoren.
- Führt interne Audits nach Plan durch und beteiligt sich bei Bedarf an externen Inspektionen und der Vorbereitung von Lizenzen und Zertifizierungen.
- Nimmt an Spezialprojekten und als Mitglied des Qualitätsteams aktiv teil.
Ausbildung und Erfahrung
- Bachelor- oder Masterabschluss (oder gleichwertiger Abschluss) in Lifesciences, medizinischer Laborwissenschaft oder Qualität
- Fliessende Französisch- und Deutschkenntnisse, Englisch und Italienisch sind ein Plus
- Mindestens 1 Jahr einschlägige Erfahrung in einer Qualitätsfunktion in der Biowissenschaftsbranche oder 1 Jahr Laborerfahrung in einem klinischen Diagnostiklabor
- Kenntnisse der ISO 15189, ISO17025 und IVDR (oder ISO 13485) sind ein Plus
- Gute MS Office Kenntnisse
Erforderliche Kenntnisse
- Gute analytische Fähigkeiten und Problemlösungsfähigkeiten.
- Gute zwischenmenschliche Fähigkeiten.
- Gute Kommunikationsfähigkeiten mit der Fähigkeit, mit internen und externen Interessengruppen zu kommunizieren.
- Gute Koordinations- und Planungsfähigkeiten.
- Reisebereitschaft innerhalb der Schweiz
- Strukturiert und gründlich, mit einem hohen Mass an Sorgfalt
- Fähig selbstständig zu arbeiten und, wenn nötig Kontakte zu knüpfen
- Guter Teamplayer
- Ein spannendes und dynamisches Arbeitsumfeld mit viel Internationalität
- Übernahme von Verantwortung und die Entfaltung Ihres Potenzials
- Ein positives Arbeitsklima mit einer partnerschaftlichen Zusammenarbeit und einer wertschätzenden und anerkennenden Firmenkultur
- Attraktive Fringe Benefits sowie eine 40h Woche und 5 Wochen Ferien
- Jahrespauschale für Ihre persönlichen Analysen und Spezialpreise für radiologische Beratung bei der Unilabs-Gruppe
Diese Stelle an einen Freund senden
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