Director Quality Management

vor 1 Woche


Mainz, Deutschland NES Global Deutschland GmbH NES Fircroft Vollzeit

Für unseren Mandanten, ein hoch innovatives BioTech Unternehmen im Rhein-Main Gebiet, suchen wir einen Director Quality Management (m/w/d) im Bereich Medizintechnik zur Festeinstellung.

Aufgaben
- Sie entwickeln das bestehende Quality Management System (QMS) weiter und bereiten es für US-Produktzulassungen vor
- Sie stellen sicher, dass das QMS alle notwendigen regionalen Vorgaben für die Vermarktung unserer Produkte in Europa und den USA erfüllt
- Sie unterweisen die Mitglieder der Produktentwicklung und Produktbetreuung darin, alle Auflagen effizient und reproduzierbar zu erfüllen
- Mit Ihrer Expertise stellen Sie sicher, dass unser QMS auf dem aktuellen Stand der Technik ist
- Sie sind der zentrale Akteur bei der Vorbereitung, Durchführung und Nachbereitung aller Audits (interne Audits, Zulieferer, Kunden, Behörden)
- Sie treiben die Weiterentwicklung und Digitalisierung des QMS eines schnell wachsenden Unter-nehmens voran

Qualifikation
- Abgeschlossenes Studium der Biologie, Quality Management, oder vergleichbare Ausbildung
- Mindestens fünfjährige Berufserfahrung im Qualitätsmanagement in der Medizin
- oder Pharmabranche, sowohl im europäischen wie auch FDA-Umfeld
- Langjährige QM-Erfahrung im IVD-Umfeld in allen Phasen des Product Lifecycles Entwicklung, Vermarktung, Änderungen und Reklamationsmanagement, Obsoleszenz
- Fortgeschrittene Kenntnisse in MS Office
- Selbständigkeit, Teamfähigkeit und Eigenverantwortlichkeit
- Bereitschaft zu regelmäßigen Dienstreisen, auch ins Ausland
- Exzellente Deutsch
- und sehr gute Englischkenntnisse in Wort und Schrift

**Benefits**:

- Ein abwechslungsreiches Aufgabengebiet
- Eine attraktive Vergütung inkl. Aktienoptionen
- Flexibilität bei Arbeitszeit und -Ort
- Flache hierarchische Strukturen
- Die Chance, sich in ein innovatives und motiviertes Team einzubringen
- 30 Tage Urlaub pro Jahr



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