4 of 4 Permanent ISO 13485 Jobs in the East Midlands

during a scan. Following initial research-market sales, we are now progressing our technology toward release as a regulated medical device and building an ISO 13485-compliant design and development capability. Description of the role: As a Design Assurance Engineer, you will play a pivotal role in enabling … from user needs to V&V evidence. Participate in cross-functional design reviews to ensure documentation is audit-ready and technically sound. Risk management (ISO 14971): Drive and maintain risk management activities as designs evolve; ensure risk controls are implemented and verifiable; facilitate workshops/coaching where required. Usability ...

team High attention to detail and ability to multi-task Initiative driven and deadline focusedCommitment to Health & Safety standards Performance Standards BS EN ISO 9001 – Quality Management Systems BS EN ISO 13485 – Medical Devices Quality Management IPC-A-610 – Acceptability of Electronic Assemblies AS9100 – Aerospace Quality Management ...

frequent travel. Desirable (nice to have): Experience in magnetic shielding, sensing, or low noise environments. Background in biomedical device installation, especially neuroimaging. Familiarity with ISO documentation practices and standards (e.g., ISO 9001, 13485). What you will bring to Cerca: Precision and reliability—ensuring every system performs ...

regulated environment. Familiarity with document management or OCR tools. Experience using Jira and Confluence. Awareness of clinical governance or quality frameworks (for example GxP, ISO 13485, DCB0129/0160). What success looks like in the first 6 months Full ownership of e-sign configuration and first-line ...