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Quality Engineer for Medical Devices (m/w/d)

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Discover Medi-Globe. Discover Innovation.

The Medi-Globe Group is an innovative, fast-growing and internationally oriented group of companies in medical technology in the field of urology and gastroenterology. Our four brands Urotech GmbH, Urovision GmbH, Medi-Globe GmbH and Endo-Flex GmbH have been developing, producing and marketing innovative instruments with excellent functionality for more than 35 years, enabling doctors to perform endoscopic procedures as precisely and successfully as possible.
 
Together with over 670 employees, we are driven by the spirit of innovation - and together we create solutions: from the idea to the market-ready product. Become part of our team, experience the fascination of our industry and actively contribute to the success of the Medi-Globe Group yourself.

YOUR CHALLANGE:

  • Monitoring software quality in application (Post-Market Surveillance) throughout the entire product lifecycle
  • Monitoring testing, correction, and release processes as part of change management
  • Responsibility for approval and registration activities (EU and RoW)
  • Responsibility for the technical documentation of medical devices
  • Responsibility for regular risk assessments, preparation of risk evaluations and reports according to ISO 14971
  • Establishing and implementing a specific complaint management system
  • Monitoring and continuously improving software development processes according to IEC 62304
  • Supporting the maintenance of an effective quality management system according to ISO 13485
  • Cooperation with various departments, particularly Research & Development, Product Management, Regulatory, and Clinical Affairs
  • Processing and responding to audit reports from the Notified Body
  • Coordination and follow-up of product changes with Notified Bodies and international cooperation partners

YOUR QUALIFICATION:

  • Completed studies in computer science, technical informatics, medical technology, or a comparable qualification
  • Extensive experience in software development, specification, and testing in front-end and back-end according to IEC 62304, IEC 62366-1
  • In-depth knowledge and experience with applications and systems in the field of medical technology / medical device approval
  • Structured, goal-oriented, and analytical working approach
  • High level of independence and reliability
  • Team player with strong communication skills
  • Willingness to travel within Europe (5-10%)
  • Very good German and English skills, both written and spoken; French is an advantage
  • Project management experience
  • Experience in the development of AI-supported software
  • Experience in preparing clinical evaluations and/or conducting clinical studies
  • Experience in cybersecurity testing
  • Experience with FDA approval processes, focusing on software as a medical device

YOUR OFFER:

  • A permanent employment contract with attractive remuneration
  • Intensive training in all areas of responsibility 
  • 40% home office share - days freely selectable
  • A strongly growing and successful group of companies
  • A dynamic working environment in a committed team that attaches great importance to teamwork
  • Flat hierarchies, direct communication and short decision-making channels
  • Company pension scheme
  • Company events, (summer party, Christmas party, autumn festival visit etc.)
  • Free drinks, coffee and fruit
  • Health promotion (JobRad, EGYM Wellpass)

YOUR CONTACT:

Personalabteilung
Medi-Globe-Straße 1-5
83101 Achenmühle