QA Engineer, Medical Devices | IVDR/ISO 13485 Expert

Rea Diagnostics SA; Vaud; On-site; CHF 90,000 - 150,000; Full time

Benefits offered by this job

Growth opportunities

ISO 13485 quality system exposure

Job summary

Rea Diagnostics SA seeks a Quality Assurance professional to develop, implement, and monitor our QMS in line with ISO 13485 and IVDR 2017/746. You report to the Management Representative and drive QA activities across teams.

The role covers supplier management, training, CAPA and SCAR processes, plus contributing to regulatory submissions and technical documentation in a growing clinical evaluation program.

Qualifications

• 2+ years in quality assurance at a medical device or IVD company.
• Strong knowledge of IVDR 2017/746, ISO 13485 and ISO 14971.
• Hands-on with document control, supplier management or training records.

Responsibilities

• Drive QA activities across teams, review quality documentation and ensure adherence to procedures.
• Manage electronic quality management system: review documents, changes and records.
• Own the training system: define and execute training plan by role, onboarding of new staff, training records.

Skills

QA experience

ISO 13485

IVDR knowledge

Regulatory affairs

Education

Engineering degree

Regulatory affairs degree

Job description

Rea Diagnostics SA seeks a Quality Assurance professional to develop, implement, and monitor our QMS in line with ISO 13485 and IVDR 2017/746. You report to the Management Representative and drive QA activities across teams.

The role covers supplier management, training, CAPA and SCAR processes, plus contributing to regulatory submissions and technical documentation in a growing clinical evaluation program.