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Quality Assurance Engineer

Quality Assurance Engineer required to join a market leading engineering manufacturing organisation, offering a competitive salary based in Cambridge.

, 2.2 or above in Engineering or other Physical Sciences
, Quality Management experience in the medical device and/or pharmaceutical manufacturing area
, Experience in FDA 21 CFR Parts 820, 211 and 210 quality system requirements.
, Experience in ISO 13485 quality management system requirements
, Experience in ISO 14971 - Application of Risk Management to Medical Devices
, Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA Good knowledge of Design History File Documents; Plans, Design Inputs, Verification, Validation, Design Reviews, Design Outputs Change Management, Discrepancy Management, Complaint Handling and CAPA
, Experience of internal/external auditing Ability to write factual reports in a methodical and timely manner
, Ability to lead projects, taking responsibility for quality, time and profit
, Bright, conscientious and creative with an ability to demonstrate a hobby or interest with a practical or technical relevance


If you feel you are the right person for this role as a Quality Assurance Engineer and have the above mentioned skills please click the "apply now" button at the bottom of your advert to progress you application further.