Quality Manager | Quality Manager (m/w/d)

anvajo GmbH

Dresden, Sachsen, Deutschland
Published Dec 1, 2025
Full-time
No information

Job Summary

This role is an exciting opportunity for a proactive Quality Manager to actively shape and advance the Quality Management System (QMS) within a modern MedTech scale-up environment in Dresden. The successful candidate will be deeply involved in development-related quality assurance, taking central responsibility for managing CAPAs, deviations, and change processes in close collaboration with development teams. Key daily activities include participation in internal, supplier, and external certification audits, acting as a secondary auditor, and managing quality-relevant tasks concerning process validation, infrastructure, and measurement equipment. The position requires strong expertise in ISO standards (especially ISO 13485 or ISO 9001), a structured, independent work ethic, and a hands-on approach to drive the digital transformation of the QMS, including supporting the introduction of new QMS software. This position offers significant responsibility and professional development potential in a company aiming to revolutionize the medical market with point-of-care diagnostic devices.

Required Skills

Education

Academic degree (e.g., Engineering, Biosciences, Medical Technology, or equivalent)

Experience

  • Several years of professional experience in Quality Management according to ISO 13485 or ISO 9001
  • Experience in a development-related corporate environment is beneficial
  • Initial practical experience handling technical deviations (Non-Conformities) and CAPA processes is advantageous
  • Practical experience as an Auditor for internal and/or supplier audits is beneficial
  • Experience accompanying external audits by certification bodies is beneficial

Languages

German (Fluent)English (Fluent)

Additional

  • Work location is primarily on-site in Dresden with the possibility for mobile working.