Senior Quality Engineer

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I am currently looking for a Senior Quality Engineer with R&D experience for a role based in Eastleigh, Hampshire.They are looking for someone to lead concept research control and design control activities, including risk management, in R&D and manufacturing, ensuring all samples, products and processes meet requirements. You will be responsible for:Maintain and update global procedures for Design Control and Risk Management that adheres to FDA CFR21 Part 820, ISO 13485, and ISO 14971.Lead and review Concept Research Control or Design Control activitiesSupport R&D in the development of the inspection methodology and acceptance criteriaProvide support to maintain Quality System Regulation requirementsWorks closely with Regulatory Affairs, and Research and Development functional groups,Participate in Regulatory Agency InspectionsSupports Manufacturing in Validation and Controlling Planning. Knowledge, Skills and Abilities:Technically sound in quality systems, and be abreast of developments in the Quality Assurance fieldPractical application of ISO 13485, ISO 14971 and FDA Quality System Regulation CFR 21 Part 820.Applied technical knowledge of Qualitative and Quantitative data analysisGMP experience mandatory. GLP, or GCP, experience ideal. If you would be interested in learning more about this role, it would be great to hear from you, please submit your CV and I will be in touch. Regards, To find out more about Computer Futures please visit www.computerfutures.com Computer Futures, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales