Description
Senior Quality Engineer (SO 13485/FDA 21 CFR Part 820/MDD 93-42-EEC)My client seeks a Senior Quality Engineer (SO 13485/FDA 21 CFR Part 820/MDD 93-42-EEC) to join they`re market leading team on a 6/12 month contract. As a Senior Quality Engineer (SO 13485/FDA 21 CFR Part 820/MDD 93-42-EEC) you will be responsible for ensuring solutions are compliant in the most efficient manner with ISO 13485, FDA 21 CFR Part 820, MDD 93-42-EEC.
You will be responsible for the approval and review of Medical Device design project quality related documentation via Oracle PLM or other systems.
As the successful candidate you will be familiar with:
-user requirements, design specifications, clinical model development, technical drawings and specifications, design verification and validation documents plus other project related documentation
-Experience of Oracle PLM, MS Excel, MS Word and Minitab or equivalent
-Leading a team in analysis techniques for designing assemblies, components and features ensuring quality, safety and efficacy features are identified
-The appraisal of the suitability of vendors and vendor supplied components
-Component qualification activity based on vendors substantiated objective evidence of process control and capability
-Approval of process validation IQ, OQ and PQ documentation
You will also have:
-Graduate level, or equivalent in Engineering/Technological discipline
-Several years experience in a Quality Engineering role in a medical device design company
Successful Senior Quality Engineer (SO 13485/FDA 21 CFR Part 820/MDD 93-42-EEC) will secure and interview early next week. All applications should be sent to Thom Pickering at Opus Recruitment Solutions via email.