Posted 4 days ago
Senior Auditor / R&D Quality Manager
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
Explore related jobs
More jobs at Da Vinci Engineering GmbH
- DReferent Asset-VertragsmanagementStuttgart, Germany
- DCAD Konstrukteur Bordnetz DMUSindelfingen, Germany
- DHomologation & Certification EngineerMainz am Rhein, Germany
- DR&D Mechatronic PTMFriedrichsdorf, Germany
- DAutomotive Support Trainer/Training DeveloperMainz am Rhein, Germany
- D(Senior) Engineer Adaptive ValidationRaunheim, Germany
Similar CAPA jobs
Jobs in Frankfurt am Main
- BMarketing Manager/-in – VollzeitBlack Forest Production GmbH · Frankfurt am Main, Hessen
- BMedia Buyer/-in - VollzeitBlack Forest Production GmbH · Frankfurt am Main, Hessen
- BSetter im Vertrieb - VollzeitBlack Forest Production GmbH · Frankfurt am Main, Hessen
- BFunnel Builder/-in – VollzeitBlack Forest Production GmbH · Frankfurt am Main, Hessen
- BVertriebsinnendienst - VollzeitBlack Forest Production GmbH · Frankfurt am Main, Hessen
- BOnline Marketing Manager/-in - VollzeitBlack Forest Production GmbH · Frankfurt am Main, Hessen
Browse these categories
Market data for this role
All reports →- SeriesRole reportsOne role family at a time: how many openings, what changed this week, who is hiring, what it pays.
- SeriesSalary reportsWhat employers publish in job postings, by level and workplace. Not self-reported pay.
- Market overviewState of tech hiring, September 2026: up 4.8%Tech hiring rose 4.8% month over month in September 2026, with 411,122 new listings. Customer support and account executive roles led the growth.