Overview

Consultys Medical and its affiliate Beyond Conception (part of Vulcain Group) are recruiting 5 QMS Specialists with a focus on Human Factors (Usability Engineering) to support projects involving complex in vitro diagnostic (IVD) medical devices classified as Class C and D under IVDR, including automated laboratory equipment (blood analyzers, immunoassay systems, molecular diagnostic platforms) used in hospital and laboratory environments.

Your Responsibilities

you will:

Integrate Human Factors / Usability Engineering requirements into the Quality Management System (QMS)
Ensure compliance with applicable standards and regulations (including ISO 13485, IEC 62366, IVDR/MDR)
Contribute to the definition and implementation of usability processes
Support risk management activities (ISO 14971) related to user interaction and use errors
Lead or support Usability Validation activities
Collaborate with R&D, Regulatory Affairs, and Clinical teams
Participate in internal audits and regulatory inspections

Profile

Engineering degree, Master’s degree, or equivalent (biomedical, quality, ergonomics, or related field)
Experience in Regulatory Affairs and/or Human Factors / Usability Engineering on Class C/D IVD devices
Experience working with or for key industry players such as Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Thermo Fisher Scientific, Danaher Corporation, QIAGEN, bioMérieux, and Bio-Rad Laboratories
Strong knowledge of Human Factors / Usability Engineering
Familiarity with standards: ISO 13485, IEC 62366, ISO 14971
Experience in regulated environments (MDR / IVDR)
Analytical mindset, attention to detail, and ability to work cross-functionally
Professional level of English
Experience with complex systems (software, laboratory equipment, connected devices)
Involvement in regulatory submissions (CE marking, FDA)
Knowledge of quality management tools (eQMS)

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Vulcain Engineering Group