Senior Auditor / R&D Quality Manager (m/f/d) (ID: 22169)

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.

Responsibilities

• 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
• On‑the‑job training and language courses
• Appreciation, motivation and commitment

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