饾棦饾槂饾棽饾椏饾槂饾椂饾棽饾槃:
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 compnays systems. This role will be responsible for both CGM and our wider product set, however CGM is the primary focus foreseen for this role.
饾棡饾棽饾槅 饾棩饾棽饾榾饾椊饾椉饾椈饾榾饾椂饾棷饾椂饾椆饾椂饾榿饾椂饾棽饾榾.
饾棫饾椀饾棽 饾椇饾棶饾椂饾椈 饾棻饾槀饾榿饾椂饾棽饾榾 饾椂饾椈饾棸饾椆饾槀饾棻饾棽 饾棷饾槀饾榿 饾棶饾椏饾棽 饾椈饾椉饾榿 饾椆饾椂饾椇饾椂饾榿饾棽饾棻 饾榿饾椉 饾榿饾椀饾棽 饾棾饾椉饾椆饾椆饾椉饾槃饾椂饾椈饾棿:
路Developing and implementing compliance strategies to support New Product Introductions and current marketed products within the areas of design, design transfer, manufacturing, and service.
路Ensuring compliance to the the companies 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.
路Lead the integration, optimisation and ongoing development of the company design and development processes into our eQMS.
路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.
路Participate in external audits as the subject matter expert for design control and associated processes.
路Provide Design Quality Engineering oversight and lead relevant design CAPA projects and non-conformance evaluations.
路Maintaining product and site certifications through successful external audits. Driving audit-readiness activities and representing the company to external agencies during audits.
路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.
路Creating the required documentation to support effective global regulatory submissions, liaising with external bodies to ensure their speedy acceptance.
路Leading activities to improve upon the design process within the company, seeking out best practice and implementing this into the QMS.
饾棫饾椀饾棽 饾棖饾棶饾椈饾棻饾椂饾棻饾棶饾榿饾棽:
路Bachelor's degree in a relevant scientific/ engineering discipline or the ability to show technical understanding of scientific/ engineering principles through industrial experience.
路>10 years substantial expertise in Design Quality Engineering in the Medical Device industry.
路Experience working with regulatory and notified bodies during submissions and external audits.
路Excellent knowledge of design control and risk management processes.
路Understanding of regulatory requirements, e.g. ISO 13485/ FDA regulations.
路Expertise in design verification and validation methodologies.
路Strong knowledge of quality management systems (QMS).
路Proficiency in conducting design reviews.
路Familiarity with industry-specific design standards and best practices.
路Excellent communication, collaboration, and interpersonal skills.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
Please apply with your CV to:
Robyn Lynch