I am keen to speak with Quality Compliance Specialists coming from a regulated manufacturing environment (Medical Device, Pharma, Life Science). This position is a 12-Month Fixed Term Contract and is offering a very competitive package (Basic, Completion Bonus Etc). You will need to have a min of 2 years working in a similar Quality Compliance position along with a detailed knowledge of and experience in Statistical Analysis, ISO 13485 and FDA 21 CFR Regulations. APPLY TODAY Quality / Compliance / QE / QA / ISO / EU MDR / pFMEAs / CAPAs / Statistical Analysis / Pharmaceutical / Medical Device / Mayo / Ireland You must be an Irish, UK or EU Citizen to work on a 12-Month Fixed Term Contract in Ireland. Job Title: Quality Compliance Specialist Location: Co. Mayo Package: Fixed Term Contract: 12 Months €55k - €65k PA Contract Completion Bonus Health Insurance 23 Days Paid Annual Leave Parking Canteen Role: The Quality Compliance Engineer is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO and the fully implemented EU MDR. Your responsibilities will include performing rigorous risk assessments (pFMEAs) and supporting the change control process to maintain product integrity. In addition, you will be a primary Quality Liaison for the production floor, supporting and driving root cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection. Key Duties and Responsibilities: Risk Management:Lead and maintain risk management files, including pFMEAs ensuring that all potential failure modes are identified and mitigated. Production Quality Support: Provide real-time QA support to the operations team to address non-conformances, perform root cause analysis, and implement effective CAPAs (Corrective and Preventive Actions). Audit Readiness: Support internal and external audits by maintaining accurate documentation and ensuring all plant personnel follow cGMP requirements. Statistical Analysis: Apply statistical techniques and tools (e.g., Minitab) to analyse process data, identify trends, and support data-driven decision-making for process improvements. Experience: Third Level Qualification (Science or Engineering Discipline) 2-5 Years Previous Experience in the medical device industry or equivalent regulated industry At Least 2 Years previous experience in a Quality / Compliance role Solid understanding of ISO 13485, EU MDR, ISO 14971 Strong analytical and problem-solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA) Proficient in data analysis tools such as Excel, Minitab, Power BI or similar Personal Characteristics: Communication: Excellent communication and presentations skills, both written and oral ability to present forecasting, capacity and other relevant planning data in a clear and concise manner to the Business Unit Planners and where required, to management Planning & Organising: Able to plan activities and tasks Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles If you would like to be considered for this opportunity follow the links below and send me your CV. Key Words: Quality / Compliance / QE / QA / ISO / EU MDR / pFMEAs / CAPAs / Statistical Analysis / Pharmaceutical / Medical Device / Mayo / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: Quality Assurance Quality Compliance Quality Engineer ISO 13485 EU MDR pFMEAs Medical Device Benefits: Annual Bonus / 13th Cheque Meal Allowance / Canteen Medical Aid / Health Care Paid Holidays Parking Performance Bonus