Description Join a leading EO (Ethylene Oxide) sterilisation plant dedicated to providing safe, effective, and high-quality sterilisation solutions. We are committed to ensuring our processes meet the highest industry standards, ensuring the safety and reliability of medical devices and other critical products. We are seeking a Quality Manager to lead our Quality Assurance and Control teams. As the Quality Manager, you will play a pivotal role in ensuring our sterilisation processes comply with regulatory standards. You will also drive continuous improvement initiatives and foster a culture of quality throughout the organisation. You will maintain the Quality Management System (QMS) within the Somercotes Facility. Responsibilities Key Responsibilities: Is the nominated Facility Management Representative with respect to ISO9001/13485/ 21 CFR Pt820 Lead and manage the quality department, overseeing all quality assurance and control activities. Develop and implement quality management systems (QMS) and procedures to maintain best practices. Conduct regular audits (internal and external) and manage customer audits and regulatory inspections. Oversee root cause analysis, CAPA processes, and quality-related investigations. Collaborate with production, R&D, and regulatory teams to ensure all products and processes meet stringent quality standards. Lead continuous improvement initiatives aimed at optimising quality processes and reducing risk. Provide training and guidance to staff on quality principles and regulatory requirements. The QA Manager has responsibility for the QA Technicians and Validation coordinators within the Somercotes facility. Qualifications Qualifications & Experience: Proven experience as a Quality Manager, ideally within EO sterilisation or a regulated manufacturing environment. In-depth knowledge of relevant standards. Strong background in managing quality systems, audits, and regulatory compliance. Excellent leadership and communication skills, with the ability to influence across departments. Degree in a relevant scientific or engineering discipline is desirable.