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Milton Keynes, United Kingdom
Quality Engineer Bedfordshire £45,000-55,000 Healthcare / Medical Devices An excellent opportunity for an experienced quality assurance/ quality engineer professional to join an established diagnostics company who are continuing to grow through new product development and innovation. They are now looking for Software Quality Engineer or a Quality Engineer who can train & develop into working more specifically on processes for software quality, design control and computer software validation- working to ISO 13485 and IEC 62304 requirements. Software Quality Engineer responsibilities Process and System Development: supports the development and maintenance of the quality management system to ISO 13485; 21 CFR Part 820 & Part 11. appropriate software design lifecycle processes, required for compliance with regulations which primarily include ISO 13485; IEC 62304. Design Control Projects: Works directly with the design & development teams to support compliance with design control requirements specifically for embedded device software. Computer Systems Validation (CSV): Responsible for generating, maintaining and improving CSV procedures. Non-Conformance Management & Audits: Supports the management of any software related deviations, quality issues or non-conformances and resulting CAPAs. Experience and Skills required: You will have Quality Engineer/ Quality Assurance experience from within a Diagnostics or Medical Device organisation (or a similar regulated health industry: biotechnology, pharmaceuticals) ISO 13485 (Medical Devices – Quality Management Systems) IEC 62304 (Medical Device Software – Software Lifecycle) US FDA 21CFR Parts 820 (Quality System Regulation) Able to demonstrate a full understanding of software lifecycle development and testing processes. Able to demonstrate awareness in the use of: ISO 14971 (Risk Management) and AAMI TIR36:2007 (Validation of software for regulated processes) If you are interested in this Quality Engineer opportunity, please contact James Powell here at TXM Recruit. TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.