NIBSC Trainee IVD Quality Officer
NIBSC Trainee IVD Quality Officer???
We are seeking to appoint a Trainee IVD Quality Officer in our Quality Assurance Group at NIBSC.
With circa 1300 staff based in two main locations and peripatetically across the UK and abroad, we enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices.
A centre of the Medicines and Healthcare products Regulatory Agency, The National Institute for Biological Standards and Control (NIBSC) is a global leader in the characterisation, standardisation and control of biological medicines. NIBSC plays a major role in assuring the quality of biological medicines worldwide through the provision of biological reference materials, by testing products and carrying out research. Our expert scientists also provide advice on a routine basis and in response to emergencies.
Purpose of the role:
This is a training position and full training will be provided to allow the successful candidate to work more independently and ultimately take responsibility for the Institute's Quality Management System (QMS) which supports Standardisation work.
The precise duties required by the post will vary with the needs of the division and the strategic objectives of the Institute, but the main duties will include supporting the ISO 13485 Quality System in line with the IVD regulation, changes to associated ISO Standards, and Institute's needs.
The successful applicant will be trained to provide advice, support, guidance and training to the Scientists with respect to Quality Management Systems and in particular ISO 13485.
BSc in a relevant biological discipline, e.g. biochemistry, microbiology, immunology or molecular biology or equivalent qualifications or relevant work experience
Skills & Experience:
Understanding of requirements of ISO 13485 QMS and knowledge of requirements for CE marking in vitro diagnostic devices
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