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Senior Auditor / R&D Quality ManagerDa Vinci Engineering · Frankfurt am Main

Senior Auditor / R&D Quality Manager

Frankfurt am MainOn-site

AI Summary

Plans and conducts clinical, process and supplier audits under GxP and regulatory requirements, leads CAPA and quality escalations, and advises Clinical Operations on quality topics. Also maintains the QMS and delivers GCP and quality training.

About this role

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!

Senior Auditor / R&D Quality Manager (m/f/d)

Stellen-ID: 22169 Standort: Frankfurt am Main

We are searching intelligent and innovative employees. If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application.

Your tasks:

  • Plan and conduct clinical project audits, process audits, and supplier/vendor audits in accordance with GxP and regulatory requirements.
  • Develop and maintain risk-based audit plans and study assessment strategies
  • Evaluate audit findings, ensure proper documentation, and support CAPA development and follow-up
  • Lead and manage quality escalations arising from clinical study activities
  • Contribute to the development and maintenance of the Quality Management System, including SOPs, CAPA, deviations, and document control
  • Provide quality consultation to Clinical Operations teams on study processes and quality-related topics
  • Support qualification and evaluation of clinical service providers such as CROs, laboratories, couriers, and archiving services
  • Deliver training on GCP, Good Clinical Laboratory Practice, and other quality-related topics

Your profile:

  • University degree in a scientific or technical field such as Life Sciences, Pharmacy, or Medical Technology
  • Several years of experience in Quality Management, Clinical Research, or auditing within a GxP/GCP-regulated environment
  • Strong knowledge of regulatory requirements for medical devices and pharmaceuticals
  • Proven experience in planning, conducting, and following up on internal and external audits
  • Solid understanding of CAPA processes, deviation management, and document control systems
  • Strong analytical skills and a structured, risk-based approach to quality oversight
  • Excellent communication and advisory skills when working with cross-functional teams and external partners
  • Very good command of English (written and spoken)

You can expect...

  • Experience in exciting and international projects
  • Continuous salary development
  • Da Vinci Corporate Benefits
  • On-the-job training and language courses
  • Appreciation, motivation and commitment

Kontaktdaten für Stellenanzeige Frau Andrea Cindric Da Vinci Engineering GmbH Hauptstätter Straße 149 70178 Stuttgart

Skills

CAPAClinical AuditsDeviation ManagementDocument ControlEnglishGCPGood Clinical Laboratory PracticeGxPMedical Device RegulationsPharmaceutical RegulationsProcess AuditsQuality Management SystemQuality TrainingRisk-based Audit PlanningSOPsSupplier Audits

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