Quality Validation Engineer required for a leading medical device client based in Cork.
In this role the Quality Validation Engineer will:
o Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
o Support process investigations providing formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes.
o Employ appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
o Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as master validation plans and risk management documentation in accordance with regulatory requirements and internal requirements. Provides guidance on the preparation and execution of computer software validation protocols, test scripts and reports to ensure all Computer System Validation (CSV) requirements are met
The Quality Validation Engineer requires:
o Bachelor’s degree from an accredited institution in a technical discipline.
o 5+ years process quality engineering experience with technical & validation/ QA experience
o Knowledge of FDA, medical device, GMP, Statistics and validation requirements.
o Experience in equipment and process validations.
o Project management, problem solving, statistical analysis, technical writing and word processing.
Call Ruth at LSC on 021 4777 329 for more information or apply directly through this advert