Quality Assurance Supervisor

vor 2 Monaten

Bayern, Deutschland Vertraulich Vollzeit

Was erwartet dich?
- Du führst das Quality Assurance Team vor Ort
- Du arbeitest in Übereinstimmung mit Qualitätssystemen gemäß ISO 17025, GLP und Kundenvorgaben
- Du bewertest Labortätigkeiten im Hinblick auf die Einhaltung der Vorschriften des Qualitätssystems (ISO, GLP und NAMSA SOPs) und ertmittelst zeitnah Abweichungen
- Du begleitest und führst interne und externe Audits durch
- Du unterstützt bei Prozess-, Geräte
- und Softwarevalidierungen
- Du überprüfst und genehmigst Untersuchungen und datenbasierte Empfehlung geeigneter Korrekturmaßnahmen bei Abweichungen (NC/CAPA)
- Du führst Schulungen in Übereinstimmung mit den gesetzlichen und NAMSA Anforderungen durch
- Du berichtest an den Quality Director EMEA
- Du arbeitest mit unserer globalen Quality Assurance Abteilung zusammen

Anforderungen

Was solltest du mitbringen?
- Du hast ein abgeschlossenes naturwissenschaftliches oder ingenieurwissenschaftliches Studium oder eine entsprechende Berufserfahrung
- Du verfügst über eine mehrjährige Berufserfahrung und Kenntnisse im Bereich Qualitätsmanagement/Qualitätssicherung nach DIN EN ISO/IEC 17025 oder ISO13485
- Du bringst Kenntnisse im Bereich GMP/GLP, Risikomanagementrichtlinien wie FMEA und ISO 14971, US FDA und EU MDD/MDR mit
- Du hast erste Führungserfahrungen
- Du verfügst idealerweise über Erfahrung mit behördlichen Schnittstellen
- Zertifizierung als leitender Auditor und Erfahrung im Projektmanagement sind von Vorteil
- Du zeigst ein hohes Maß an Eigeninitiative und Verantwortungsbewusstsein sowie eine ausgeprägte Hands-on Mentalität
- Du bist ein Teamplayer mit Kommunikationsstärke
- Du punktest mit deinem Organisationstalent und einer strukturierten Arbeitsweise

Wir bieten

Was bieten wir dir?
- Eine anspruchsvolle und abwechslungsreiche Tätigkeit in einem global expandierenden Unternehmen
- Ein hochprofessionelles Team sowie ein internationales Arbeitsumfeld
- Eine attraktive, leistungsgerechte Vergütung
- Flexible Arbeitszeiten mit flexiblen Home-Office-Möglichkeiten
- Arbeitgeberzuschuss zur betrieblichen Altersvorsorge
- Monatlicher Freibetrag zum Tanken des privaten PKW
- Benefits wie regelmäßige Team Events und Betriebsrestaurant mit Außenterrasse

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