Quality Assurance Engineer, IVD / Medical Devices

About the role

Rea Diagnostics is developing a home‑use self‑test for preterm labor risk. The Quality Assurance Engineer will support the implementation and monitoring of the Quality Management System (QMS) in line with ISO 13485 and the IVDR, reporting to the Management Representative.

Key responsibilities

• Drive QA activities across teams, review and approve quality documentation, and ensure procedural compliance.
• Manage the electronic QMS, including document changes, records, and supplier quality agreements.
• Own the training system: define role‑based training plans, onboard new staff, and maintain training records.
• Oversee equipment qualification, calibration, and maintenance in collaboration with production.
• Participate in CAPA management, internal audits, and SCAR handling.
• Assist R&D in drafting technical documentation and validation reports.

Required profile

• Minimum 2 years of quality assurance experience in a medical device or IVD company under ISO 13485.
• Strong knowledge of IVDR 2017/746, ISO 13485 and ISO 14971.
• Engineering or science degree (Bachelor/Master) in Quality Assurance or Regulatory Affairs.
• Fluent in written and spoken English and French.
• Right to work in Switzerland or EU/EFTA citizenship; no sponsorship offered.

Required skills

• ISO 13485 document control
• IVDR 2017/746 compliance
• ISO 14971 risk management
• Supplier evaluation and quality agreements
• Training record management

What we offer

• Opportunity to shape the future of maternal and reproductive healthcare.
• Work with an established ISO 13485 quality system and experienced Management Representative.
• Close collaboration with R&D and production on a product in clinical evaluation.
• Training support for professional development.