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Quality Process Consultant job in Slough

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Job Ref:  68971223
Employer:  My Job Matcher
Country:  United Kingdom
City:  Slough
Post Code:  SL1
11/10/2016 16:40
My client are a global engineering company based in the south of England. They are looking for an Electronics FDA / CSV Process Consultant on a 6 to 12 month contact initially to support the development and delivery of an electronics process compliant to ISO13485:2016. You must have a proven track record in delivering projects on track and with strong stakeholder management skills and strong industrial experience in developing electronic processes. Objectives: - Direct and facilitate a small team developing electronic processes compliant to ISO13485, in order to meet Class I (A) medical device classification in line with 21 CFR 820.- Develop hardware, software, and systems processes in accordance with ISO13485.- Engage with existing internal and external consultants to ensure process alignment.- Make use of existing internal processes to facilitate development of compliant processes.- Facilitate electronics development teams in application of ISO13485 compliant processes. Experience required: - Proven track record of developing and delivering process documentation to ISO13485.- Experience in 21 CFR 820, IEC62304, IEC60601, and ISO14871.- Strong technical background in hardware, software and/or systems engineering within the medical devices arena.- Ability to plan and estimate tasks (ideally within an Agile framework).- Quality Management, Sytems validation- Strong interpersonal skills. Please apply as soon as possible for further information. Remuneration for this role is c.50 per hour. Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Contracts are those of an Employment Business.
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