I'm delighted to be working with an excellent client of ours based in Athlone on this Quality Systems Engineer role. This is a permanent position and the chance to join a very exciting team, where you will get exposure to various QA activities.Position SummaryThe Quality Systems Specialist is responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable U.S. and international regulations and standards, includingFDA 21 CFR Part 820,ISO 13485,ISO 27001, and other applicable regulatory requirements. This position supports both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devicesKey ResponsibilitiesMaintain the Quality Management System (QMS) and activities to ensure that all operations are fully in compliance with FDA, ISO, and other regulatory requirements.Maintain quality system procedures, work instructions, and records.Ensure timely and accurate document control and change management activities.Track and report metrics and key performance indicators for the Quality Management System.Monitor and trend quality system metrics (CAPAs, complaints, audit findings, etc.) and prepare reports for management reviews.Support Corrective and Preventive Actions (CAPA) by conducting root cause investigations, effectiveness checks, and documentation.Assist with risk management processesContinuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments, reporting via site metrics, KPI's and Quality Management ReviewManagement of the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.Support / host Client quality audits. Inclusive of addressing findings and required actions.Document Control - Site lead for managing SOPs and Document Control.Site lead for training compliance to SOPs.Other duties as required to support the growing Quality organisation.Building authentic relationships, ensuring cross-functional Quality Systems meetings are held so that Quality Systems can collaborate with all stakeholders of the QMS to drive improvementsTravel RequirementsFlexibility to travel to the US is required to support business activities and Quality Audits.Qualification, Skills and ExperienceBachelor's Degree in a Science Related DisciplineMinimum 3 to 5 years of professional experience in the Medical Device industry in Quality Assurance role.Previous experience in Medical Device software an advantage.Experience in current QMS requirements and extensive knowledge of ISO 13485 is required, knowledge ISO 27001 regulations is an advantageStrong, clear and concise communicator both internally and externally.Team Oriented: Ability to integrate with the Company Core Values, culture, and team climate.Detail Oriented: Ability to focus on the details yet understand the overall direction.Self-Motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it.Good organizational and presentation skills, ability to communicate Quality Metrics to management