NPI Quality Engineer required by leading medical devices company based in Waterford City. The overall purpose of this role is:- The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Supports New Product Introduction activities relating to Quality for products, processes, or technologies, and for the enhancement or extension of existing product lines. Key Responsibilities and End Results: NPI Provide technical support during the NPI process in ensuring that from a Healthcare / Medical device / Medicinal Product perspective that all FDA, QSR, MDR & EU GMP standards/guidelines are achieved and maintained in respect to device classifications. Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, FMEAs & support the generation of DMFs and other applicable regulatory documents where appropriate. During validation phase, support the development of a compliant manufacturing process aligned to the Customers expectations, ensuring the process & product are operational ready post validation. Utilize continuous improvement methodologies and process capability analysis to provide a robust defect free process. Support the transfer of ownership from NPI to Production phase, liaising with Programmes group and operational workcell. Ensure projects are prioritized in line with business needs. Support Quality Lead NPI with on-going projects and new business developments. QA Individual with an experienced background in sterilisation, automation, equipment/software validation, manufacturing within controlled environments. Individual shall support the external & internally Quality Management System auditing function. Individual shall have exposure & involvement in supporting the CAPA system. Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company. Support the implementation of Company Policies and GMP. Support all company safety and quality programs and initiatives. Ensure ongoing compliance with GMP in all practices, recording of events and processes. Ensure compliance with all learnings from all GMP training events. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position. Requirements :- The minimum education and experience required to perform this job competently. BSc Degree in a life science (or similar) discipline. 2-4 years experience in manufacturing (preferably Medical Device/Pharmaceuticals) Organisational and planning skills are required to plan, execute and track quality commitments Working knowledge of ISO 13485 &/or Pharmaceutical EU GMP (Eudralex Volume 4) Experience of performing audits of quality systems to ISO/GMP standards Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual). Excellent organisation, communication, computer & presentation skills. Excellent initiative, decision making and be able to work in a core team environment. Excellent time management skills. Solution driven with emphasis on performance and results Skills: Quality Engineering Validation CAPA GMP Benefits: pension Healthcare