2 of 2 ISO 13485 Jobs in Swindon

successful in this role, you will ideally have: Experience within Medical Devices, Diagnostics or another highly regulated manufacturing environment. Strong knowledge of ISO 13485 and Quality Management Systems. Experience managing CAPAs, non-conformances, complaints and root cause investigations. Knowledge of quality tools such as 8D, 5 Why, Fishbone … process improvement initiatives. Exposure to supplier quality, change control and risk management activities. Strong documentation and problem-solving skills. Experience with Technical Documentation, ISO 14971, UK MDR, EU MDR, Design Controls or validation activities would be advantageous. Excellent stakeholder management and communication skills. Please note: sponsorship is not available ...

need to succeed You will have: Previous Quality Engineering experience within medical devices or another highly regulated manufacturing environment Strong knowledge of ISO 13485 and medical device quality systems Experience managing non-conformances, CAPA and root-cause investigations Knowledge of quality tools such as 8D, 5 Why, Fishbone … Good knowledge of UK MDR and EU MDR, particularly Technical File generation, maintenance or remediation A relevant engineering, scientific or technical qualification Experience with ISO 14971, design controls, process validation, complaint handling, supplier quality or internal auditing would be advantageous. What you'll get in return You will receive ...