Quality Management Representative (Medical Devices) | Biologe (m/w/d)

SIGNUS Medizintechnik GmbH

Alzenau in Unterfranken, Bayern, Deutschland
Published Dec 16, 2025
Full-time
No information

Job Summary

This role requires a dedicated professional to serve as the central point of contact for all quality-relevant topics within an international medical technology company specializing in high-end spinal implants. Day-to-day activities involve maintaining, developing, and monitoring the Quality Management System (QMS) according to ISO 13485 and MDR, including the creation and digitalization of QM documents. The representative will lead internal audits, coordinate external audits with notified bodies and authorities, and manage customer complaints, root cause analysis, and the coordination of Corrective and Preventive Actions (CAPA). Key qualifications include a university degree in a medical or natural science field and proven experience in medical device quality management, coupled with fluent German and English skills. This is an attractive opportunity within a growing family-owned business offering flat hierarchies, flexible working hours, and significant responsibility in a challenging, international environment.

Required Skills

Education

University Degree in Medical or Natural Sciences

Experience

  • Professional experience in medical device quality management
  • In-depth knowledge of ISO 13485, MDR, and other relevant standards
  • Experience in conducting internal audits and coordinating external audits
  • Experience in handling customer complaints and implementing corrective actions

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified