Product Verification

vor 4 Monaten

Stuttgart, Deutschland KLS Martin Group Vollzeit

Product Verification & Validation Specialist, Monitoring (m/w/d)

Chirurgische Innovationen zu entwickeln ist unsere Leidenschaft. Kompetenz, Motivation und Engagement unserer Mitarbeiter sind dafür entscheidend. Deshalb sind wir immer auf der Suche nach Menschen, die sich Ziele setzen, Ideen entwickeln und offen für Neues sind. Werden auch Sie ein Teil chirurgischer Innovation und tragen Sie so dazu bei, die Lebensqualität der Menschen zu verbessern.

Was Sie erwartet
- Video ansehenMit dem Laden des Videos aktzeptieren Sie die Datenschutzerklärung von YouTube. Zum Abspeieln akzeptieren SIe die Cookies von YouTube

Was wir bieten
- **Individuelle Einarbeitung**
- mit Onboarding-Programm und persönlichem Paten.- **Aus
- und Weiterbildung**
- für Ihre persönliche Entwicklung mit unserer finanziellen Unterstützung.- **Flexibles Arbeiten**
- mit Gleitzeit und mobilem Arbeiten von bis zu 60%.- **Sport
- und Gesundheitsangebote**
- wie BusinessBike, Hansefit, Yoga und Gesundheitstage.- **Cafeteria**
- mit kostenlosem Wasser und wechselnden Essensangeboten.- **Angebote zur Vorsorge**
- wie betriebliche Altersvorsorge und vermögenswirksame Leistungen.- **Wachsendes Familienunternehmen**
- das für persönliche Nähe, unkomplizierte Entscheidungswege sowie Sicherheit und Stabilität steht.- **Innovation und spannende Produkte**
- die vielfach neue Maßstäbe setzen und Menschen helfen.Was Sie tun
- Erstellung von Monitoringplänen und -berichten für das gesamte Produktportfolio
- Beauftragung von Tests bei ausgewählten zertifizierten Laboratorien
- Einteilung des gesamten Produktportfolios in Produktfamilien
- Beurteilung von Entwicklungsprojekten
- Koordination mit anderen Abteilungen bei Out-of-Specification Ereignissen(OOS)
- Risikobewertung von Ereignissen im Hinblick auf bestehende Validierungen und Entwicklung von Strategien im Falle eines OOS-Ergebnisses
- Zusammenarbeit mit verschiedenen Fachabteilungen für die Prüfung der Produktdokumentationen im Hinblick auf die Bestimmung der worst-case Kriterien und der Erhebung von Daten
- Priorisierung der Aufgaben nach den allgemeinen Projektzielen und dem Validierungsmasterplan
- Als Monitoringverantwortliche*r sind Sie Teil des Produktvalidierungsteams und unterstützen andere Bereiche der Produktvalidierung wie beispielweise der Reinigungsvalidierung, Sterilisationsvalidierung, Aufbereitungsvalidierung, Transportvalidierung, Verpackungsvalidierung und der Prüfung der biologischen Sicherheit.

Was Sie mitbringen sollten
- Erfolgreich abgeschlossenes technisches oder naturwissenschaftliches Studium oder alternativ eine vergleichbare technische Ausbildung
- Erste Berufserfahrung im Bereich Implantate, Instrumente und elektrische Medizinprodukte wünschenswert
- Kenntnisse von relevanten Normen und Vorschriften, insbesondere der MDR, ISO 13485 ISO 14971, ISO 19227 und ANSI/AAMI ST72 sowie der Mikrobiologie sind von Vorteil
- Gute Kenntnisse im Umgang mit Microsoft365
- SAP-Kenntnisse von Vorteil
- Sehr gute schriftliche und mündliche Kommunikationsfähigkeiten in Deutsch sowie gute Englischkenntnisse für die Zusammenarbeit mit internationalen Behörden und englischsprachigen Kollegen
- Motivierter Teamplayer mit einer lösungsorientierten Einstellung
- Strukturierte Arbeitsweise

Interessiert?

Dann bewerben Sie sich doch einfach direkt hier online. Unsere Mitarbeitenden schätzen die Kollegialität und die Zusammenarbeit in den Teams. Wir suchen neue Teammitglieder, Menschen mit Persönlichkeit, die unsere Werte teilen und gemeinsam mit uns die Zukunft gestalten wollen. Unterstützen Sie uns an unserem Standort in Mühlheim an der Donau.

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