Quality Assurance Engineer, IVD / Medical Devices (ISO 13485)

Rea Diagnostics SA; Lausanne; On-site; CHF 90,000 - 120,000; Full time

Benefits offered by this job

Growth in healthcare

ISO 13485 quality system exposure

Collaborative R&D & Production

Job summary

Rea Diagnostics SA in Lausanne, Switzerland, seeks a Quality Assurance professional to develop, implement and monitor the QMS in compliance with ISO 13485 and IVDR 2017/746. You report to the Management Representative and collaborate closely with R&D and Production during clinical evaluation stages.

You will drive QA activities across teams, manage the electronic QMS, training, supplier management and CAPA processes while contributing to technical documentation and regulatory activities.

Qualifications

• 2+ years in quality assurance at a medical device or IVD company under ISO 13485.
• Strong knowledge of IVDR 2017/746, ISO 13485 and ISO 14971.
• Engineering degree or Bachelor/Master in Science, Quality Assurance or Regulatory Affairs; hands-on experience with document control, supplier management or training records.
• Fluent English and French, both written and spoken.
• Right to work in Switzerland, or EU/EFTA citizenship; we cannot sponsor work permits for this role.

Responsibilities

• Drive QA activities across teams, review/approve quality documentation and ensure adherence to procedures.
• Manage our electronic quality management system: review/approve quality documents, changes and quality records.
• Own the training system: define/execute 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.
• Lead equipment and infrastructure-related activities: qualification, calibration and maintenance, together with our production team.
• Take part in the management of CAPA, audits and SCAR.
• Contribute to the drafting of technical documentation and validation reports together with the R&D team.
• Provide ad-hoc support to Quality Control, Clinical and Regulatory activities

Skills

Quality Assurance

ISO 13485

IVDR 2017/746

Regulatory Affairs

Documentation Control

Supplier Management

Training Records

CAPA

Education

Engineering degree

Bachelor/Master in Science

Quality Assurance

Regulatory Affairs

Job description

Many tests in maternal and reproductive health can only be done in a hospital or clinic. Rea Diagnostics, an EPFL spin-off, is developing tests that patients can use in the comfort of their home.

Today, a woman with symptoms of preterm labor has to go to the hospital for an exam that tells her and her doctor whether she is at risk of imminent delivery. 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 patients and their doctors information sooner, so doctors can guide them through pregnancy.

PremaSure™ is being evaluated in a clinical performance study in Europe 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 support the development, implementation and monitoring of the QMS in compliance with ISO 13485 and IVDR 2017/746. You report to our Management Representative.

What you will do

• Drive QA activities across teams, review/approve quality documentation and ensure adherence to procedures.
• Manage our electronic quality management system: review/approve quality documents, changes and quality records.
• Own the training system: define/ execute 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.
• Lead equipment and infrastructure-related activities: qualification, calibration and maintenance, together with our production team.
• Take part in the management of CAPA, audits and SCAR.
• Contribute to the drafting of technical documentation and validation reports together with the R&D team.
• Provide ad-hoc support to Quality Control, Clinical and Regulatory activities

Requirements

• 2+ years in quality assurance at a medical device or IVD company, working under ISO 13485.
• Strong knowledge of IVDR 2017/746, ISO 13485 and ISO 14971.
• Engineering degree or Bachelor/Master in Science, Quality Assurance or Regulatory Affairs. Hands-on experience with document control, supplier management or training records.
• Fluent English and French, both written and spoken.
• 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.

What we offer

• The opportunity to grow in a company shaping the future of maternal and reproductive healthcare.
• An established ISO 13485 quality system and an experienced Management Representative to work with.
• Close work with R&D and production on a product in clinical evaluation.