Job Description
MCS Group is proud to be working with an innovative Medical Laboratory to recruit a Quality Officer on a Temporary Contract basis to be based out of Belfast.As the Quality Specialist/Officer, you will play a pivotal role in ensuring compliance with ISO 13485 and ISO 15189 standards, as well as IVDD compliance. This role involves managing the Quality Management System (QMS), overseeing risk management processes, and preparing for and participating in internal and external audits.You will:Maintain and continuously improve the QMS to ensure compliance with ISO 13485 and ISO 15189 standards, and IVDD regulations.Conduct regular reviews of the QMS and recommend improvements to ensure ongoing compliance and efficiency.Identify, assess, and manage risks associated with lab operations, processes, and products.Participate in audits, providing necessary documentation and responses to auditors.Lead the transition efforts to new versions of the ISO standards, ensuring all processes and documentation are updated accordingly.Assist in the preparation and transition to In Vitro Diagnostic Regulation (IVDR) accreditation.Ensure all relevant processes and documentation meet IVDD and IVDR requirements.Monitor the effectiveness of quality improvement activities and report on progress to the Quality Manager.Essential Requirements:Bachelor's degree in a relevant field (e.g., Biology, Chemistry, Quality Management, or a related discipline), minimum GCSE A Grade in English and Maths.At least 3 years of experience in a quality role within a diagnostic or clinical laboratory environment.Experience with ISO 13485, ISO 15189 standards, IVDD compliance, and IVDR accreditation preparation.Strong knowledge of QMS principles and practices.Relevant certifications in Quality Management (e.g., Certified Quality Auditor, Certified Quality Engineer) are a plus.To speak in absolute confidence about this opportunity, please send an up-to-date CV via the link provided or contact Amy Wallace, Specialist Consultant at MCS Group 028 9049 0898. #J-18808-Ljbffr