5 of 5 ISO 13485 Jobs in the South West

recruit an experienced Quality Engineer to join their manufacturing team and support the ongoing development of their Quality Management System in line with ISO 13485 and regulatory requirements. This is an excellent opportunity for someone with a strong background in manufacturing who enjoys working across the full quality … CAPA management to validation, supplier quality and continuous improvement. Key responsibilities include: Maintaining and improving the Quality Management System (QMS) Planning and conducting ISO 13485 internal audits and supporting external audits Managing CAPAs, non-conformances, root cause investigations and change control Supporting supplier quality, validation activities and complaint ...

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 ...

mission-critical or highly regulated software . Desirable Skills & Experience Experience developing medical devices or other safety-critical systems . Knowledge of IEC 62304 , ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...

safety-critical, mission-critical or highly regulated software. Desirable Skills & Experience Experience developing medical devices or other safety-critical systems. Knowledge of IEC 62304, ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...