Specialist Technical Documentation | Spezialist Technische Dokumentation (m/w/d)
Orizon GmbH NL Frankfurt
Job Summary
This role is for a Specialist in Technical Documentation supporting an innovative medical device software project for a leading international healthcare company in Bad Homburg. The specialist will be crucial in ensuring the quality and compliance of new device software by performing technical verification and managing comprehensive documentation. Day-to-day tasks involve executing technical verification, applying and implementing technical documentation standards (primarily in English), and creating, maintaining, and approving project planning documents. The position requires collaboration within the verification team, utilizing automated approval systems like Trackwise and Documentum, and generating status reports and documentation metrics. Ideal candidates must possess a technical background, initial experience in software testing/QA, excellent technical English skills, and knowledge of regulatory frameworks such as ISO 13485 and FDA processes, ensuring high precision in a regulated environment.
Required Skills
Education
Completed technical training (e.g., IT, Electronics, Mechatronics, or comparable)
Experience
- Initial knowledge in software testing / Quality Assurance (Test cases, error logs, tools)
- Experience with automated approval and tracking systems (e.g., Trackwise, Documentum)
- Experience with medical device technology and interfaces (Desirable)
- Professional experience working in regulated environments
Languages
Additional
- Position is initially limited to 12 months (temporary contract via agency).
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