CSA Group tests, inspects and certifies a wide range of products to meet exacting requirements for safety, performance and environmental impact
Job Summary
CSA Group tests, inspects and certifies a wide range of products to meet exacting requirements for safety, performance and environmental impact.
The Assessor conducts management system audits on-site, remotely or in the form of a document review and assesses medical device product files up to class III.
The role is expected to contribute to a statement on conformity and a recommendation for certification of the client.
Matching Summary
CSA Group tests, inspects and certifies a wide range of products to meet exacting requirements for safety, performance and environmental impact.
Skills & Requirements
Must-have
Quality management systems audits
Medical device technical file assessment
Clinical data evaluation
ISO 13485
MDR/IVDR regulations
Nice-to-have
Analytical thinking
Conflict resolution
Autonomous working mode
Ethical behavior
Team player
Key Requirements
Min. six years of professional experience in healthcare products/medical devices/IVD
Min. four years of professional experience in quality management systems
Min. five product file reviews per year over the last three years (for product reviewer)
Min. thirty on-site audit days in min. three third-party audits as lead auditor per year over the last three years (for on-site auditor)
University degree in medical or scientific field or comparable professional knowledge