Job Title

Are you an experienced Quality Assurance professional looking for a hands on leadership role in a fast-paced environment? We are seeking a Quality Assurance Manager to support a leading provider of gamma sterilisation services within the medical device and healthcare industry.About the Role:This is a key quality leadership position within a smaller, specialist operation, offering a fantastic opportunity to make a real impact. You will be responsible for maintaining and improving quality systems, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR Part 820, and leading a small quality team of two.Key Responsibilities:Oversee and maintain the Quality Management System (QMS) in compliance with medical device and sterilisation regulationsManage audits, CAPA investigations, non conformances, and document controlAct as the primary quality contact for internal and external stakeholders, including regulatory bodies and customersSupport continuous improvement initiatives to enhance quality and efficiencyProvide hands on leadership to a small team, ensuring training and developmentWho We’re Looking For:Experience in quality assurance within medical devices, pharmaceuticals, or sterilisationKnowledge of gamma sterilisation processes (preferred, but not essential)Strong understanding of ISO 13485, ISO 9001, 21 CFR 820, and regulatory complianceHands on approach, comfortable working in a smaller, fast paced operationSome leadership or supervisory experience (doesn’t have to be extensive)Need to be flexible to working conditions with occasional travel locally & aborad/Why Apply?Work in a specialist industry with a growing demand for sterilisation servicesMake a direct impact in a key quality leadership roleJoin a tight-knit team where your contributions are highly valuedInterested? Apply today or contact us for more details!