Quality Control/Assurance Engineer
4 days ago
Leeds
Job Summary Medasil Surgical Limited is seeking a Quality Control/Assurance Engineer to support 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, established in 1974, is a renowned manufacturer of silicone tubing and surgical devices utilized in operating theatres. Based in Leeds, the company supplies high-quality products to the NHS, private hospitals, and specialist clinics across the UK, as well as exporting globally. Duties and Responsibilities • Goods-in material inspection and product release, • In-process and final quality control inspections, • Review and sign off batch documentation, • Equipment inspection, 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 Requirements Essential: • 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 or similar role, • Experience in metrology and understanding Technical drawings. Desirable: • Knowledge of ISO13485, EU-MDR 2017/745 and MDD 93/42/EEC, • LEAN manufacturing understanding, • Cleanroom experience, • Degree in Engineering, Quality Management, or a related field is preferred 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) If you're interested in contributing to high-quality medical device manufacturing in a regulated environment, apply today.