Qualification Engineer - Kenilworth, United States - BlueWave Solutions

Michael Johnson

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Michael Johnson

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Description

Your tasks

  • Creating project-specific qualification documents and reports
  • Planning and conducting qualification of medical production equipment
  • Planning and conducting concept and design FMEAs
  • GMP-compliant documentation during project duration
  • Accompanying customer acceptance tests (FAT/SAT) at the factory and at customer sites
  • Continuously improving existing qualification strategy

Your profile

  • Completed engineering degree, degree in natural sciences or medical technology
  • Familiar with GMP regulations and common industry standards
  • Excellent technical understanding in the field of special mechanical engineering
  • Professional experience in qualifying medical equipment
  • Service and customer-oriented mindset combined with a focus on company interests
  • Excellent German and English skills, as well as strong communication, cooperation, and teamwork abilities
  • Good knowledge of MS Office

We offer

  • Exciting and diverse tasks
  • Individual, flexible working hours and modern workspaces
  • Friendly and innovative company culture with flat hierarchies
  • Future security and stability through international orientation with the HAHN Group
  • Excellent development opportunities
  • Challenging and performance-based compensation and bonuses
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