Software Quality , Medical Devices (ISO 13485)

South East England
26 Feb 2013
26 Mar 2013
Andrew Nitek
Full Time
Software Quality Analyst required by leading medical devices manufacturer based in the South East. This role will encompass working in both a software quality/ Computer Systems Validation (CSV) and medical device IS)13485 / IVD environment where you will be providing expert quality systems advice on both a technical and strategic basis. This is a superb opportunity to gain experience of working in a cutting edge IVD environment, and to work with a with a world class brand. In order to be considered you will need solid software quality assurance experience, coupled with experience of the following: ISO13485, ISO14971, ISO13485/ISO 9001, IEC62304, IEC/TR80002-1, AAMI TIR36:2007, AAMI TIR45:2012, GAMP5, ISO27002, 21CFR Parts 820 and 11 and Directive 98/79/EC. A detailed knowledge of software interconnection, communication/ wireless standards would be highly advantageous.

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