2 of 2 Contract ISO 13485 Jobs in England

and product validation, iterating based on test results and feedback. Collaborate with suppliers on design reviews, ensuring cost-effective, reliable manufacturing. Ensure compliance with relevant regulatory and quality standards (ISO 9001, CE, RoHS, EMC considerations). Support root cause analysis and continuous improvement (CI) activities during and post NPI. Document processes and design changes, maintaining alignment with engineering change … understanding of DFM/DFA principles. Ability to work closely with cross-functional teams (electronics, firmware, quality, production). Experience in risk assessment, FMEA, and quality documentation aligned with ISO 9001 or similar. Comfort with prototyping, debugging, and iterative design. Nice to Have Experience in RFID/NFC, barcode scanners, or imaging devices mechanical design. Familiarity with ISO 13485, ISO 14971, or similar regulated environments. Exposure to Lean Manufacturing, Six Sigma methodologies. Experience designing test fixtures for production and QA. Familiarity with IP rating considerations for rugged devices. Why us? Work on real hardware products that ship globally. See your designs in use in airports, banks, and secure environments worldwide. Join a collaborative, engineering-led More ❯

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 ❯