Quality Engineer (Fixed-Term) – Medical Device Industry An exciting opportunity has arisen for an experienced Quality Engineer to join a dynamic team on a fixed-term basis to cover maternity leave. This role offers the chance to contribute to cutting-edge projects within the medical device sector, working on innovative solutions that enhance healthcare. About the Company This organisation provides contract design, development, and manufacturing services to medical device companies, with a focus on disposable components of diagnostic tests, particularly in point-of-care in vitro diagnostics (IVD). With advanced in-house manufacturing capabilities, including biosensor fabrication, assay development, and device assembly, the company is dedicated to delivering high-quality solutions to a global client base. Operating from a modern facility in the UK, the team thrives in a forward-thinking, collaborative environment that fosters innovation and excellence. The Role The Quality Engineer will play a key role in ensuring compliance with regulatory standards while supporting product and process development. Responsibilities include providing quality oversight, supporting design control activities, and assisting in validation and verification (V&V) processes. Additionally, the role will involve contributing to non-conformance investigations, managing CAPA processes, and supporting audits. Key Responsibilities Provide quality oversight for design controls and risk management activities. Review and approve equipment qualification and process validation (IQ/OQ/PQ) to meet regulatory and business requirements. Maintain and manage the electronic Quality Management System (eQMS). Review and approve quality documentation, including validation protocols, change controls, and non-conformance reports. Engage with clients on quality matters as required. Support audits from regulatory agencies, notified bodies, and clients. Assist in or lead CAPA and non-conformance investigations. Candidate Profile Essential: Qualified in engineering or a scientific discipline (or significant industry experience in lieu of academic qualifications). Proven experience in the medical device industry. Strong knowledge of ISO 13485 and FDA regulations (CFR 21 Part 820). Extensive experience with equipment and process validation (IQ/OQ/PQ). High proficiency with electronic Quality Management Systems (eQMS). Understanding of design controls and the product development lifecycle. Strong problem-solving skills and attention to detail. Excellent written and verbal communication skills. A proactive approach with a strong sense of accountability. Desirable: Experience with Dot Compliance. Certified internal auditor qualification. Green Belt or experience in Process Excellence. Competence in statistical analysis and software validation. Why Apply? This is an excellent opportunity to gain experience in a rapidly evolving industry, working on high-impact projects with a talented and supportive team. The organisation values innovation, accountability, and collaboration, offering a dynamic work environment where professional growth is encouraged.