Software Quality , Medical Devices (ISO 13485)

South East England
Negotiable
26 Feb 2013
26 Mar 2013
PR-12338478
Andrew Nitek
Healthcare
IT
Permanent
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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