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Danaher Corporation Quality Leader (m/f/d) in Dassel, Germany

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

What you'll do

  • Managing the Site Quality Management System, fully integrated into the Cytiva Quality Management System, including cross-functional and site-specific processes. The role has a responsibility for facility compliance covering all quality requirements

  • Maintaining and improving all aspects of Site Quality Planning.

  • Participating in all Quality-related communications and training requirements for all site employees.

  • Establishing positive relationships with outside agencies.

  • Participating in site audit readiness and hosting Quality System audits and inspections.

  • Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering.

  • Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.

  • Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.

  • Participating in selected global initiatives to share best practices and leverage quality synergies.

  • Supporting local R&D programs and quality issue resolution.

Who you are

  • Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 8 years work experience)

  • Minimum 4 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.

  • Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities.

  • Experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.

  • Proven track record in performing external and internal audits with preferably a Professional certification as a Lead Auditor.

  • Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.

  • Effective report, business correspondence and procedure writing skills.

  • Good problem identification, multivariable analysis and creative resolution aptitude.

  • Proven process development and project management skills.

  • Strong computer skills.

  • Ability to communicate in German and English

Who we are

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !

Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.

Zu Ihrem Aufgabengebiet zählen u.a.

  • Verantwortlich für die Verwaltung, Pflege und Verbesserung des Site Quality Management Systems und funktionsübergreifender sowie standortspezifischer Prozesse der Standortqualitätsplanung

  • Teilnahme an allen qualitätsbezogenen Kommunikations- und Schulungen für alle Mitarbeiter vor Ort

  • Beschwerdemanagement des Quality Engineering

  • Berichtswesen und Durchführung von Qualitätsmanagement-Reviews und Audits

  • Teilnahme an ausgewählten globalen Initiativen zum Austausch und Schaffung von Qualitätssynergien

  • Unterstützung lokaler R&D Programme

Erforderliche Qualifikationen

  • Bachelor-Abschluss in Ingenieurwesen, Medizintechnik oder Naturwissenschaften (oder eine fachbezogene Ausbildung mit mindestens 8 Jahren Berufserfahrung)

  • Mindestens 4 Jahre Berufserfahrung in der Produktentwicklung, Herstellung, Qualitätskontrolle und Wartung medizinischer Geräte oder pharmazeutischen Industrie

  • Mindestens 3 Jahre Managementerfahrung, einschließlich Einstellungen, Schulungen, Coaching

  • Erfahrung mit FDA-, QSR-, ISO-, MDD- und / oder anderen internationalen Qualitätssystemanforderungen

  • Nachgewiesene Erfolgsbilanz bei der Durchführung externer und interner Audits, vorzugsweise mit einer Professional-Zertifizierung als Lead Auditor

  • Analysieren und Interpretieren von Geschäftsplänen, technischen Verfahren und behördlichen Vorschriften

  • Problemlösungsorientiert und kommunikationsstark

  • Fließende Kenntnisse in Deutsch und Englisch

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .