Descripción
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 part