Software Quality , Medical Devices (ISO 13485)

Location
South East England
Salary
Negotiable
Posted
26 Feb 2013
Closes
26 Mar 2013
Ref
PR-12338478
Contact
Andrew Nitek
Sector
Healthcare
Function
IT
Contract Type
Permanent
Hours
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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