Product Quality Assurance Engineer (Medical Devices)

Vector Recruitment Ltd
£400 - £420 per day
27 Sep 2016
20 Oct 2016
We have an urgent new contract requirement for a Project Quality Engineer with a background in medical device development. The assignment will be based just outside Cambridge for an initial 12months duration, Rate - circa £400-420 per day. Working in conjunction with engineering development teams and the internal QA Dept, the Project Quality Engineer will be responsible for assessing and assuring compliance with key medical device product development standards such as ISO 13485, ISO 14971, ISO 62304 ISO 62366 and 21 CFR part 820. This will include creation and approval of documentation required to support medical device product development (eg planning, requirements, architecture, verification/validation etc.) spanning both hardware and software. Contract location: rural South Cambridgeshire Contract Duration: 12month initial assignment Assignment start: ASAP Pay Rates: circa £400-420 per day Essential Qualifications and experience for Contract Project Quality Engineer (Medical Devices) Degree or HND/HNC in a technical discipline -eg Electronics Engineering, Mechanical Engineering, Software Engineering or similar. Proven experience in quality assurance in a medical device development environment including regulatory requirements such as ISO 13485, ISO 14971, ISO 62304, ISO 62366 and 21 CFR part 820 Experience of complete product development lifecycle within a multidisciplinary team using recognised development methodologies Knowledge of a variety of risk management tools, design and process control activities, verification and validation testing methodologies Good written and verbal communication skills Desirable skills & Experience Knowledge of Lean and 6 sigma tools and techniques eg DFMEA, PFMEA SPC, design of experiments and root cause analysis (DMAIC,8D) Certified Lead Auditor ISO 13485 / 9001 Experience of working with 'Agile' methodologies. For more information please contact Adam Mayne at Vector Recruitment Ltd This job was originally posted as

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