Quality Assurance Engineer (m/f/d)

Responsibilities

• Own and execute the product release process for Custom Engineering Dreieich products,
• ensuring compliance with QMS, regulatory, and customer requirements.
• Own, maintain, and harmonize Custom Engineering SOPs within the global QMS.
• Coordinate cross‑functional reviews, change control activities, and related training to ensure
• global implementation and compliance.
• Manage customer complaints, including timely assessment, documentation, response, and
• trend analysis.
• Manage Deviations and CAPAs in QMS, ensuring effective root cause analysis,
• implementation of corrective actions, and timely closure.

Requirements

• Bachelor's degree in engineering or science discipline.
• Minimum 2-3 years of experience in Quality role, preferably in the Life Sciences industry.
• Good knowledge of using MS Office tools such as MS Excel to perform analytics and data
• management.
• High attention to detail, good coordination skills, and ability to work cross‑functionally with
• global QA & Engineering teams.
• Ability to communicate effectively in both German and English (written and spoken).
• It would be a plus if you also possess previous experience in:
• Knowledge and awareness of the methods and techniques of Quality Control in the
• manufacturing industry.
• Technical knowledge of systems/devices used in the biopharma field.
• ISO 9001
• Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and
• technology. We partner with customers across the globe to help them solve their most complex challenges,
• architecting solutions that bring the power of science to life.
• For more information, visit www.danaher.com.
• Bringen Sie mehr ins Leben.
• Sind Sie bereit, Ihr Potenzial zu beschleunigen und einen echten Unterschied in den Bereichen Life Sciences, Diagnostik und Biotechnologie zu machen?
• Bei Cytiva, einem der über 15 operativen Unternehmen von Danaher, rettet unsere Arbeit Leben - und wir alle verfolgen das gemeinsame Ziel, Innovationen mit messbarem Impact voranzutreiben.
• Sie arbeiten in einer inklusiven Unternehmenskultur, in der Ihre Perspektive zählt. Durch das kontinuierliche Verbesserungssystem von Danaher tragen Sie dazu bei, Ideen schnell in konkrete Ergebnisse umzusetzen.
• Die Arbeit bei Cytiva bedeutet, an der Spitze neuer Lösungen zur Verbesserung der menschlichen Gesundheit zu stehen. Unsere Kunden leisten lebensrettende Arbeit - von der Grundlagenforschung bis hin zur Entwicklung innovativer Impfstoffe, Medikamente sowie Zell- und Gentherapien.
• **Ihre Aufgaben**
• Verantwortung für den Produktfreigabeprozess im Bereich Custom Engineering Dreieich unter Einhaltung von QMS-, regulatorischen und kundenspezifischen Anforderungen
• Erstellung, Pflege und Harmonisierung von SOPs im globalen QMS
• Koordination funktionsübergreifender Reviews, Änderungsprozesse (Change Control) und Schulungen zur Sicherstellung der globalen Umsetzung
• Bearbeitung von Kundenreklamationen inkl. Bewertung, Dokumentation, Rückmeldung und Trendanalyse
• Management von Abweichungen und CAPAs im QMS inkl. Ursachenanalyse, Maßnahmenumsetzung und fristgerechtem Abschluss
• **Ihr Profil**
• Abgeschlossenes Bachelorstudium in Ingenieurwesen oder Naturwissenschaften
• Mindestens 2-3 Jahre Erfahrung im Qualitätsbereich, idealerweise in der Life-Sciences-Branche
• Gute Kenntnisse in MS Office, insbesondere Excel für Analysen und Datenmanagement
• Hohe Detailge

Additional Information

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. The Quality Assurance Engineer (m/f/d) for Cytiva is responsible for maintaining and improving the Quality Management System by ensuring Cytiva, Customer, and Regulatory requirements are being met through project execution and delivery of product. This position reports to the Site Quality Manager and is part of the Custom Engineering Quality Assurance department located in Dreieich and will be an on-site role.

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