Arbeitgeber: Da Vinci Engineering GmbH

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
+49 711 72240 107
job@davinci.de