Quality Control/Assurance Engineer Medical Devices

Job Summary Medasil Surgical Limited is seeking a Quality Control / Assurance Engineer to support Medical Device manufacturing operations through inspection , compliance , and quality activities. The role is hands-on and primarily focused on production . The successful candidate shall contribute to maintaining and improving various aspects of the QMS system. The role reports to the QA/RA Director. Company Description Medasil Surgical Limited is a leading UK-based medical device company specialising in the design, manufacture, and supply of single-use surgical products. With a strong reputation for quality, and customer focus, we are committed to delivering safe and effective solutions to healthcare professionals worldwide. Duties and Responsibilities • Goods-in material inspection and product releas e • In-process and final quality control inspections • Review and sign off batch documentation • Equipment in spec tion , maintenance logs and calibration activities • Environmental and bioburden monitoring • Cross functional departmental training for compliance • Record and report rejects and rework. • Support Change control , on-conformance , Supplier approvals and Customer requests. • Assist in maintaining accurate QMS records and documents. • Ensure compliance with ISO 13485 EU-MDR and UK-MDR regulations and cGMP. • Support continuous improvement initiatives • Support validation and FMEA activities. • Maintain safe and clean working area • Occasional heavy lifting • Requires walking between various areas , standing , sitting bending and reaching Essential Requirements: • Experience in medical device industry or similar regulated environment • Knowledge of ISO 13485, EU-MDR and UK-MDR regulations and cGMP. • Experience working with Quality Management Systems or similar • Proficient in Microsoft Office applications • Strong attention to detail • Excellent written and verbal communication skills • Minimum of 4 year's previous experience in Quality control / Assurance • Experience in metrology and understanding Technical drawings. • Degree in Engineering, Quality Management, or a related field is preferred Desirable: • Knowledge of ISO13485, EU-MDR 2017/745 and MDD 93/42/ EEC • LEAN manufacturing understanding • Cleanroom experience Skills • Strong organisational and time management skills • Self-motivated and adaptable • Team player with good interpersonal skills • Good manual dexterity • Ability to work under tight deadlines and change in priorities • Internal auditor (preferable) Medasil Surgical Limited is an equal‑opportunity employer. We welcome applications from all qualified individuals regardless of background and identity. If you're interested in contributing to high-quality medical device manufacturing in a regulated env ironm e nt , apply today. This is a full‑time, permanent on‑site role based in Leeds, UK. Please only apply if you are able to commute to our Leeds location or are willing to relocate.