Quality Assurance Engineer Our top client based on the Mayo/ Galway border is seeking an experienced Quality Assurance Engineer to work within a cross-functional team to bring expertise in ISO 13485 to the wider Engineering, Operations, and R&D teams. Any applicant must have experience in the medical device industry, with a proven track record implementing and managing internal Quality Assurance systems and managing internal audits. The ideal candidate will have a strong understanding of equipment design. This role is not suitable for an individual from the Automotive industry. Any applicant must be residing in Ireland and have an existing visa Stamp 4 or an EU passport to apply. (No visa sponsorship is offered for this role.) Daily duties will include: Write & update QMS elements and ISO 13485 procedures, processes, forms, and templates for Global Engineering. Act as the Global Engineering ISO 13485 SME for the Global Validation Lifecycle including key subsystems such as Equipment Qualification, Risk Management, Process Validation, etc. Monitor and maintain the quality and compliance status of associated records, procedures, work instructions, and training materials for the GE department. Liaise with local teams to ensure compliance is maintained. Ensure documentation readiness, provide technical input and present as a Global Engineering SME on relevant topics during regulatory inspections. Provide technical interpretation and guidance of current EU validation, US FDA, CE Markings & any other relevant standards. Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Quality Management System (QMS) requirements, including ownership, as relevant. Provide Technical input to risk assessments, audits, regulatory inspections and incident investigations. Support Global Engineering in the technical writing of Test/ Study / Validation Protocols, Test methods and SOPs, or reports as needed. Support on training documentation - templates, procedures, with regards to ISO13485 and QMS. Deliver training on any existing and new ISO13485 / QMS documentation relevant to the Global Engineering Department. Create software documentation after a thorough collaboration with subject matter experts and technical staff Governance of Global Engineerings CAPAs and deviations, change control Part-take in cross-functional problem-solving teams for troubleshooting and investigations Key requirements: Bachelor's degree in Manufacturing Engineering, Bio-Medical Engineering, Chemistry, or similar technical field, with a minimum 5 years relevant Quality experience in a regulated environment (ISO13485/FDA). Excellent Quality Management System knowledge required. Practical experience with ISO 13485, FDA Quality system regulations, Good manufacturing practices, good documentation practices and other applicable standards. Experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques. Have technical accuracy in writing user documentation. Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures. A dynamic team-player and problem solver who can work effectively on multiple cross-functional teams and projects. Excellent organisational skills, attention to detail & systematic approach to work. Strong Interpersonal & presentation skills. Communicate complex ideas in a concise manner Lucrative salary, and benefits package available for the right candidate. Interested? Reach out to Niamh at or today. Skills: Quality Assurance ISO 13485 equipment validations.
