Job Description
????????????????: Our Continuous Glucose monitoring device is a key pillar of growth for the organisation as we look to enter new markets with an innovative device, providing a more sustainable and accessible alternative to diabetes patients globally. To support this innovative products development, we now require a Senior/Principal Design Quality Engineer to develop and implement compliance strategies to support New Product Introductions (NPI) and current marketed products within the areas of design, design transfer, manufacturing, and service. As a critical member of the NPI core team you will ensure adherence to the Quality Management System (QMS) and regulatory requirements. By employing strong critical thinking and influencing skills you will work cross-functionally to ensure robust Quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness and execution and enable commercial delivery of the companys systems. This role will be responsible for both CGM and our wider product set, however CGM is the primary focus foreseen for this role. ?????? ????????????????????????????????. ?????? ???????? ???????????? ?????????????? ?????? ?????? ?????? ?????????????? ???? ?????? ??????????????????: Developing and implementing compliance strategies to support New Product Introductions and current marketed products within the areas of design, design transfer, manufacturing, and service. Ensuring compliance to the Trinity Biotech QMS and regulatory requirements (e.g. 21 CFR 820, ISO 13485, MDR) while driving process effectiveness and efficiency. Ensuring plans, protocols, results, and conclusions are generated, reviewed, and approved according to applicable procedures. Lead the integration, optimisation and ongoing development of Trinity Biotech design and development processes into our eQMS. Performing internal audits, for example assessing compliance of the Design History File (DHF) and other programme files, to ensure Quality standards and regulatory requirements are addressed. Participate in external audits as the subject matter expert for design control and associated processes. Provide Design Quality Engineering oversight and lead relevant design CAPA projects and non-conformance evaluations. Maintaining product and site certifications through successful external audits. Driving audit-readiness activities and representing Trinity Biotech to external agencies during audits. Providing design control guidance and coaching to the wider Quality and R&D teams, partnering with them to ensure a seamless process from design through to registration. Creating the required documentation to support effective global regulatory submissions, liaising with external bodies to ensure their speedy acceptance. Leading activities to improve upon the design process within the company, seeking out best practice and implementing this into the QMS. The Candidate Bachelor's degree in a relevant scientific/ engineering discipline or the ability to show technical understanding of scientific/ engineering principles through industrial experience. >10 years substantial expertise in Design Quality Engineering in the Medical Device industry. Experience working with regulatory and notified bodies during submissions and external audits. Excellent knowledge of design control and risk management processes. Understanding of regulatory requirements, e.g. ISO 13485/ FDA regulations. Expertise in design verification and validation methodologies. Strong knowledge of quality management systems (QMS). Proficiency in conducting design reviews. Familiarity with industry-specific design standards and best practices. Excellent communication, collaboration, and interpersonal skills. Attention to detail and a high degree of accuracy. Ability to work effectively in cross-functional teams. Strong organisational and time management skills. Adaptability and flexibility in handling changing priorities and requirements. Ability to work independently and take initiative. Leadership and teamwork skills. Continuous learning mindset to stay updated with evolving technologies and industry practices Adecco Ireland is acting as an Employment Agency in relation to this vacancy. Skills: Design Engineering Quality Medical Device