3 of 3 ISO 13485 Jobs in the North of England

to work in the UK Genedrive is a pioneering medical device company headquartered in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a … Degree-qualified in a science or engineering discipline Minimum 3 years of experience in a QA/RA role within the IVD or medical device sector Solid understanding of ISO 13485 and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams … Desirable: Knowledge of IEC 62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO 13485:2016 Lead Auditor training This role is a unique chance to step into a high-impact position within a fast-moving and rewarding sector, apply now More ❯

procedures, identify instrument/component performance, ensuring all observations and data are recorded. Analysing results and experimental data to determine pass/fail. All activity to comply to ISO9001 & ISO 13485 (cGMP) Responsible to the Maldi Test Manager for: Final test of MALDI TOF instrument systems, checking their performance for reliability and specification levels under a various conditions. … team measures, facilitating and driving continuous improvements. When required, train new engineers and peers. Correct use of tools and processes, described in SAMI's & Test procedures. Comply to ISO9001 & ISO 13485 (cGMP) If required Commissioning of instruments within the U.K. and R.O.W. territories Qualifications (E/D): Degree/HND science/engineering basis; Chemistry, Physics, Biological, Electronics More ❯

Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO 13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯