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Quality Assurance Specialist
vor 1 Monat
Join our team at Maquet Cardiopulmonary GmbH
We are looking for a highly motivated and experienced Quality Systems Engineer to join our team in Hechingen or Rastatt. As a Quality Systems Engineer, you will be responsible for the development and implementation of quality management systems, including the creation and review of procedures and work instructions.
Your tasks:
- Pflege und Weiterentwicklung des Quality Management Systems, einschließlich der Erstellung und Prüfung von Verfahrens- und Arbeitsanweisungen sowie zugehörigen Formblättern
- Beratung / Coaching von Prozesseigner*innen bei der Erstellung von SOPs etc., in Bezug auf QMS Compliance
- Schulung und Unterweisung von allen Mitarbeitenden hinsichtlich Compliance und anderer qualitätsrelevanter Themenfelder
- Bearbeiten von Quality System relevanten Abweichungen (in CAPA bzw. NC)
- Untersuchung der Ursachen sowie Definition und Umsetzung von Korrekturmaßnahmen
- Planung, Durchführung und Koordination von internen Audits
- Unterstützung bei externen Audits (Third Party Audits / FDA, DEKRA etc.) sowie bei Management Reviews
Your profile:
- Erfolgreich abgeschlossenes Ingenieursstudium der Fachrichtung Medizintechnik, Kunststofftechnik oder Maschinenbau oder eine vergleichbare Ausbildung
- Idealerweise mehrjährige Berufserfahrung im Bereich der Medizintechnik
- Fundierte Kenntnisse im Qualitätswesen
- Kenntnisse in den Bereichen Qualitätsmanagement für Medizinprodukte ISO 13485, Quality System Regulation 21 CFR 820, Risikomanagement für Medizinprodukte ISO 14971, GMP für Medizinprodukte sowie dem Medizinproduktegesetz (MPG)
- Statistikkenntnisse sind wünschenswert
- Präsentations- und Moderationsfähigkeiten gepaart mit einem ausgeprägten Sinn für Projektmanagement sowie Zeit- und Selbstmanagement zeichnen Sie aus
- Sehr gute Deutsch- und Englischkenntnisse (in Wort und Schrift) runden Ihr Profil ab
We offer:
- Hochwertige Produkte im lebensrettenden Umfeld
- Vergütung nach Metalltarif, 30 Urlaubstage pro Jahr und weitere attraktive Konditionen
- Flexible, familienfreundliche Arbeitszeiten und mobiles Arbeiten
- JobRad und Corporate Benefits (Mitarbeiterrabatte)
- Karrierechancen in einem namhaften Unternehmen
- Individuelle Einarbeitung und Weiterbildungsmöglichkeiten
- Moderne Arbeitsplatzausstattung
About us
We at Getinge are convinced that every person and every society should have access to the best possible healthcare. That's why we offer hospitals and life science companies products and solutions that improve clinical outcomes and streamline workflows. Our portfolio includes products and solutions for intensive care, cardiovascular interventions, operating rooms, sterilization and life science. Getinge employs almost 12,000 people worldwide and sells its products in over 135 countries.
