Careers

Examen is currently recruiting. Please see our available positions and information on how to apply below.

Quality Manager

ExamenLab Ltd is a medical diagnostics company, based in Belfast, Northern Ireland developing clinical decision support tools for the diagnosis and treatment of male reproductive health issues.

Examen is using single cell gel electrophoresis techniques developed by the company to determine sperm DNA damage. Our unique technology provides diagnostic tools for male fertility and miscarriage and predictive tools for success using different forms of fertility treatment.

These services will be available to healthcare professionals involved in the diagnosis and treatment of men with infertility and also in research projects with academic institutes.

We are seeking an experienced Quality Manager who will be responsible for the establishment of IVDR, CE and UKCA marks and also the maintenance of our quality management system to meet our ISO:13485 requirements. You will be responsible for implementing and managing core QMS processes (CAPA, supplier management, document control, etc.) as well as quality assuring specific medical device development processes (risk management, configuration management, clinical studies etc.). You will oversee all quality aspects of maintenance of a clinical diagnostics laboratory, including planning and achieving IVDR certification and also maintaining our ISO:13485 accreditation.

Working closely with our senior leadership team, this position requires:

• Relevant industry background in a quality management position (ideally with molecular diagnostics experience).
• Prior experience maintaining a QMS aligned with ISO:13485.
• Previous experience in attaining IVDD and CE marking.
• Preparation experience for external audit by regulatory bodies (UKAS, notified body, FDA or similar agency).
• Planning, initiating and managing quality improvement projects.
• Experience in conducting internal and external audits.
• Prior line management experience.

Successful candidates will also possess an ability to recognise, analyse and problem solve complex issues. You will be well organised and able to work independently and within a team setting.

This is a permanent position, based in a growing company with the potential for real world impact coupled with an excellent, friendly working environment whose headquarters are based in Belfast, Northern Ireland, with a competitive salary and benefits package.

Please send your CV with a covering letter to careers@examenlab.com.

Salary range £40,000-45,000