Job Title: Quality (QUA) Engineer Location: Athlone Contract Type: 12-Month Fixed Term Working Hours: Monday to Friday, 9:00am to 5:00pm (39 hours per week) Pay Rate: €32.63 per hour Start Date: ASAP Number of Positions: 1 Purpose of the Role: The QUA Engineer will be responsible for initiating and executing defined quality activities aimed at improving or developing new systems and processes. This role plays a vital part in ensuring product quality, regulatory compliance, and continuous improvement within a regulated environment. Key Responsibilities: Initiate and complete technical and cost-saving activities for process improvements including risk documentation, test methods, process/software validation, and procedural updates. Initiate, review, and approve change controls. Perform statistical analysis and interpret data using appropriate statistical tools and methods. Develop and implement effective sampling strategies. Write and review CAPAs, non-conformance reports (NC/NCMRs), and supplier corrective action requests (SCARs). Ensure ongoing compliance in Product Manufacturing, Packaging, and Labelling. Conduct internal and supplier audits to verify compliance. Support and participate in external audits by regulatory bodies (e.g., ISO, FDA). Collect, compile, and analyse Quality Metrics and other performance data. Maintain compliance with training requirements and associated documentation. Follow Environmental, Health and Safety (EHS) and CGMP policies and procedures. Contribute to the continuous improvement of compliance initiatives across the business. Required Experience: Minimum of 3 years' experience in a regulated environment, preferably within the medical device sector or an FDA/ISO 13485 certified environment. Required Skills: Strong attention to detail. Strong computer proficiency, especially in MS Excel, PowerPoint, and Word. Familiarity with statistical tools (e.g., Pareto charts, trend analysis). Experience with risk management tools such as FMEAs and root cause analysis. Strong problem-solving skills. Clear and effective communication skills - both verbal and written. Ability to work in a fast-paced, team-oriented environment. Experience in change control implementation within a medical device setting. Demonstrated adherence to CGMP and compliance standards. Education: A degree-level qualification in Quality, Science, or Engineering is required. Additional Information: Flexibility to travel and support business needs if required. This is a team-based role and the ability to collaborate effectively is essential. Skills: Communication Time Management Team Work