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. 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 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. 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 . Qualified in engineering or a scientific discipline (or significant industry experience in lieu of academic qualifications). Proven experience in the medical device industry . High proficiency with electronic Quality Management Systems (eQMS) . Competence in statistical analysis and software validation . 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.
Contact Detail:
Kleboe Jardine Ltd Recruiting Team