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Qualitätsmanager (m/w/d) at zollsoft GmbH

Department: QualitätsmanagementSeniority in posting: experienced

Language
Setup
Remote - Germany
Location
Jena, Thuringia · Hamburg · +9
Type
Full-time, Part-time
Level
mid
Posted

Description

tPM is hiring a Quality Management Specialist to develop and maintain its quality management system for medical devices, including software and AI-based products. The role covers documentation, regulatory requirements such as MDR, ISO 14971, ISO 13485, IEC 62304, IEC 62366-1, and the AI Act, audits, quality data reporting, and process improvement. It is primarily a full-time position with a 100% home-office setup in Germany, with part-time work possible for at least 30 hours per week. Applicants should have a technical or natural science degree, prior experience with medical devices, strong German communication skills, and knowledge of relevant quality and regulatory standards.

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