We are working on an exciting Quality Engineer role for a large medical device client in Clonmel.Key Roles & Responsibilities:Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.Required Qualifications:2-5 years' experience in Manufacturing or Quality with a honours degree qualification in Engineering or related technical/Quality discipline.Excellent written and verbal communication skillsDemonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problemsStrong command of MS Office – Word, Excel, PowerPoint.Ability to rapidly learn and use new applicationsPreferred Qualifications:Previous experience in a Quality, or Manufacturing background.Experience in the medical device industry.Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.Experience in problem solving and process improvement methodologies.Process Validation, Risk Management, CAPA experience.