Complaint Investigator (m/w/d)

Fresenius Medical Care

Schweinfurt, Germany
3+ years medical device complaint management
Knowledge of iso 13485 and qms requirements
Experience with capa and root cause analysis
The role involves independently investigating complaints regarding active medical devices for Fresenius Medical Care's Schweinfurt location

Job Summary

  • The role involves independently investigating complaints regarding active medical devices for Fresenius Medical Care's Schweinfurt location.
  • Candidates will coordinate investigations with production, development, and suppliers while documenting results in the QTRAK system.
  • The position offers opportunities for career development within a global team dedicated to improving patient lives through innovative kidney care.

Matching Summary

The role involves independently investigating complaints regarding active medical devices for Fresenius Medical Care's Schweinfurt location.

Skills & Requirements

Must-have

  • 3+ years medical device complaint management
  • Knowledge of ISO 13485 and QMS requirements
  • Experience with CAPA and root cause analysis
  • Proficiency in QTRAK Complaints AMD system
  • Technical background in engineering or technician role

Nice-to-have

  • Familiarity with Trackwise system usage
  • Understanding of dialysis and ECCT procedures
  • Experience with FMEA and statistical methods
  • Project and risk management skills
  • Fluent English and German language skills

Key Requirements

  • Bachelor degree in engineering or equivalent technical qualification
  • Minimum 3 years experience in complaint handling for medical products
  • German and English language proficiency required

Work Rights

Not specified

Tailored Resume

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