QMS Specialist IVD laboratory equipment Class C/D

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)