Our client, a global leader in the Medical Device industry, are looking to recruiting an R&D Quality Engineer on a 12 fixed term contract for their site in Cork.
- Leads the development and introduction of quality systems to support the Research, Development and Introduction of new Products, Processes and Technologies.
- Has responsibility for quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer whilst ensuring compliance to FDA Quality System Regulations and ISO 13485.
- Lead the implementation of quality systems and work closely with Design, Quality and Manufacturing Engineering personnel on product and process design during the development and introduction of new products and technologies. Ensure that customer requirements are incorporated into product functional specifications and lead risk and failure analysis (FMECA/PFMEA) to ensure functional specification requirements are fully met during design validation.
- Working from the design input requirements, functional specifications and risk analysis, develop necessary confidence levels and derive the resulting product and process validation and test plan. Interpret test results to predict product reliability.
- Provide process validation support both internally and with vendors. Technically understand the process in question, develop and provide input to process validation protocols, coordinate inspections and analyze the results. Ensure agreement on inspection techniques, equipment and acceptance criteria. Work with the Project Team to achieve a robust validated process.
- Bachelor?s Degree within Engineering or a related discipline
- 2+ years? experience within a similar role
- Working knowledge of CAD/CAM/CAE computer systems advantageous
- Excellent analytical skills and promotes a problem solving work style
For further information on this R&D Quality Engineer role in Cork, please contact Cliona O'Malley on 091730022 / email@example.com
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