JOB PURPOSE:Reporting to the QE Leader Leader the Quality Engineer shall lead from a Quality perspective.The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion.MAIN DUTIES & RESPONSIBILITIES:Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Technology) into production with the highest level of quality, compliance, and adherence to timelinesCompile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in productionDevelop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product DevelopmentLead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.Lead QA input to Design for Manufacture activities on site.Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO / requirements etc. during all day to dayProvide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.Assist in the development, review and approve product, gauge, tooling and fixturing drawings.Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements.QUALIFICATIONS & EXPERIENCE-A degree level or similar qualification.-Minimum 1 years experience in a quality role within a regulated industry.-Proven ability to successfully introduce new product development in the Medical Device Industry.-Proven knowledge and ability regarding product verification and process validations.-Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.-Proven experience and training in Mechanical Engineering processes.