Senior Quality Manager Qualification and Validation (m/w/d)
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Über Heraeus Medical
Wieder mobil werden bei schwerer Arthrose oder Knochenerkrankungen? Operationsergebnisse mit Knochenzement verbessern? Heraeus Medical bietet fortschrittliche Lösungen von der Orthopädie bis zum Infektionsmanagement. Exzellente Qualität treibt uns an und bringt Freude zurück – ins Leben von Patienten und in Ihren Job.
Was haben Sie vor? Spielen Sie bei Heraeus Medical in der Top-Liga der Medizintechnik!
Heraeus Medical mit Sitz in Wehrheim (Deutschland) ist eine Operating Company der Heraeus Gruppe. Diese liefert in den Bereichen Metals & Recycling, Healthcare, Semiconductor & Electronics und Industrials Qualität auf Weltklasseniveau. Als eines der Top-10-Familienunternehmen in Deutschland beschäftigt Heraeus rund 15.200 Mitarbeitende in 40 Ländern.
Das können Sie bewegen:
- Als Senior Quality Manager Qualification & Validation führen Sie neue Produkte und Prozesse aus der Entwicklung in einen stabilen Routinebetrieb.
- Dabei planen und steuern Sie Projekte eigenständig, halten Termine und Budget im Blick und sorgen für Transparenz in der Umsetzung.
- Komplexe, verkettete Anlagen qualifizieren Sie für einen sicheren, regelkonformen Betrieb.
- Herstellprozesse validieren Sie risikobasiert und belegen die Prozessfähigkeit auditfest.
- Mit fundierten Prozessrisikoanalysen identifizieren Sie Schwachstellen, definieren Maßnahmen und sichern deren Wirksamkeit.
- Pläne, Protokolle, Berichte sowie Vorgabedokumente entstehen unter Ihrer Federführung – klar strukturiert und normkonform.
- Als Ansprechpartner des Produktionsbereichs klären Sie Prozessfragen im Tagesgeschäft und geben Orientierung.
- Im Schulterschluss mit Entwicklung, Qualität und Produktion arbeiten Sie interdisziplinär und bringen Vorhaben zielgerichtet voran.
Das bringen Sie mit:
- Abgeschlossene technische Ausbildung sowie Erfahrung im Bereich Qualitätsmanagement/-sicherung
- Mindestens 5-jährige Berufserfahrung im Bereich Qualifizierung & Validierung
- Erfahrung in den Themengebieten Verpackungsprüfung & Sterilisation
- Ausbildung als Validierungsbeauftragte*r und Six Sigma Black Belt
- Sehr gute Kenntnisse relevanter regulatorischer Anforderungen, insbesondere GxP, ISO 13485, Quality System Regulation (FDA) und zugehöriger Normen
- Routine in angewandter Statistik (SPC, MSA, DOE) für risikobasierte Planung und Umsetzung von Qualifizierungen und Validierungen
- Kenntnisse in Computer System Validation (CSV)
- Sicheres Deutsch und Englisch sowie routinierter Umgang mit gängigen Anwenderprogrammen
- Analytische, lösungsorientierte und kommunikationsstarke Persönlichkeit, die interdisziplinäre Zusammenarbeit schätzt, proaktiv vorgeht und Freude an der Dokumentation hat
Worauf Sie sich bei Heraeus Medical freuen können:
- Spannende Aufgaben – setzen Sie diese mit hoher Eigenverantwortung in einem ambitionierten Umfeld mit sehr guten Weiterentwicklungsmöglichkeiten um
- Attraktive Vergütung - starkes Grundgehalt nach Chemie-Tarifvertrag, jährliche Einmalzahlungen (Urlaubsgeld, 13. Tarifgehalt, Zukunftsbetrag) sowie Erweiterung der gesetzlichen Pflegeversicherung um eine Pflegezusatzversicherung
- Finanzielle Zusatzleistungen - Förderung der privaten Altersvorsorge, Lebensphasenkonto für bezahlte Freistellungen (z.B. Sabbatical, früherer Eintritt in den Ruhestand), Rabatte in vielen (Online-)Shops, Fahrradleasing
- Geregelte Arbeitszeiten - 37,5 Wochenstunden, wöchentlich 1-2 Tage mobiles Arbeiten, Freizeitausgleich für Überstunden, Altersfreizeiten, 30 Tage Jahresurlaub, Sonderurlaub für besondere Anlässe
- Gesundheit & Wohlbefinden - betriebsärztlicher Dienst mit umfassenden Vorsorgeuntersuchungen, Sozialberatung und hauseigene Mitarbeiterkantine mit täglich frisch zubereiteten Speisen
- Nachhaltigkeit und soziales Engagement - Nachhaltigkeit als Teil der Unternehmensstrategie und gezielte Förderung von Initiativen aus den Bereichen Bildung, Familie und Wissenschaft durch eigene Stiftungen
ReqID: 58887
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