QA Engineer – IVD & Medical Devices (Lausanne)

Rea Diagnostics SA; Lausanne; On-site; CHF 90,000 - 130,000; Full time

Job summary

Rea Diagnostics SA in Lausanne (EPFL Innovation Park) on site is seeking a Quality Assurance Specialist to run our quality system daily and oversee training, suppliers and operations. Reporting to the Head of R&D, you will ensure ISO 13485 practices are followed and maintain records.

Responsibilities include electronic QMS management, training program ownership, supplier evaluation and quality agreements, equipment qualification and CAPA activities, plus writing technical docs with the R&D team.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality assurance

Documentation control

Supplier management

Training records

English proficiency

French proficiency

Education

Science degree (chemistry/biology/molecular biology)

Tools

QMS software

Document control system

Job description

Rea Diagnostics SA in Lausanne (EPFL Innovation Park) on site is seeking a Quality Assurance Specialist to run our quality system daily and oversee training, suppliers and operations. Reporting to the Head of R&D, you will ensure ISO 13485 practices are followed and maintain records.

Responsibilities include electronic QMS management, training program ownership, supplier evaluation and quality agreements, equipment qualification and CAPA activities, plus writing technical docs with the R&D team.