1 of 1 Traceability Matrix Jobs in the East of England

Quality Management System, with practical application of IEC 62304 and ISO 14971.Act as the firmware compliance leader, guiding the team on requirements management, traceability, risk control implementation, verification strategy, and evidence generation. Work closely with Quality and Regulatory teams to define, implement, and maintain firmware-related QMS processes … templates, and work instructions. Produce, review, and approve key firmware deliverables including requirements, architecture and design documentation, risk analyses, traceability matrices, and verification reports. Skills & Experience 5+ years hands-on experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages ...