Quality Assurance Engineer – IVD / Medical Devices (ISO 13485) (f/m/d)

Rea Diagnostics SA · EPFL Innovation Park, Lausanne (on site) · 80–100% · Start as soon as possible

Our mission

Many tests in women’s health can only be done in a hospital or clinic. Rea Diagnostics, an EPFL spin-off, is developing tests that women can use at home.

We start with pregnancy, a time full of unknowns. Today, a woman with symptoms of preterm labour has to go to the hospital, sometimes in the middle of the night, for an exam that tells her and her doctor whether she is at risk. We are developing PremaSure™, a self-test to bring this exam home: a self-collected swab and a paper strip, with a result in minutes. The aim is to give women and their doctors information sooner, so doctors can guide them through pregnancy.

PremaSure™ is under clinical investigation in three European countries and is not yet available for sale. Rea is supported by Switzerland’s leading grants and awards for research and entrepreneurship. We are a team of 7, based in Lausanne.

The role

You run our quality system day to day and take charge of training, suppliers and operations. You report to our Head of R&D.

What you will do

• Run our electronic quality management system: document control, change control and quality records.

• Own the training system: training plan by role, onboarding of new staff, training records.

• Manage suppliers and purchasing: supplier evaluation and approval, quality agreements, follow-up with our contract manufacturers.

• Keep equipment and infrastructure under control: qualification, calibration and maintenance, together with our production team.

• Take part in CAPA, audits and supplier non-conformities.

• Write technical documentation and validation reports with the R&D team.

Requirements

• 2+ years in quality assurance at a medical device or IVD company, working under ISO 13485.

• A degree in chemistry, biology, molecular biology or a related science.

• Hands-on experience with document control, supplier management or training records.

• Fluent English and working French. Our contract manufacturers work in French.

• Right to work in Switzerland, or EU/EFTA citizenship. We cannot sponsor work permits for this role.

Nice to have: lab or R&D experience before moving to quality; immunoassays or lateral flow tests; IVDR; experience with an electronic QMS; internal auditor training.

How to apply

Send your CV and your notice period to [email protected], or apply on LinkedIn.