9 of 9 ISO 13485 Jobs in the 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 ...

also lead improvements that reduce turnaround times, streamline processes, improve reporting, introduce best practice and prepare the department for future regulatory requirements, including ISO 13485 compliance. Why this role is unique: This isn't a typical service leadership role. You’ll be working at the intersection of: Assistive … systems. Strong organisational skills with the ability to manage competing priorities. Excellent written and verbal communication skills Desirable experience: Medical devices and regulated products. ISO 13485 and quality management systems. Six Sigma methodologies. CAPA investigations. Business Central. Electronics fault-finding to component level. #J-18808-Ljbffr ...

also lead improvements that reduce turnaround times, streamline processes, improve reporting, introduce best practice and prepare the department for future regulatory requirements, including ISO 13485 compliance. Why this role is unique: This isn't a typical service leadership role. You'll be working at the intersection of: • Assistive … systems. • Strong organisational skills with the ability to manage competing priorities. • Excellent written and verbal communication skills Desirable experience: • Medical devices and regulated products. • ISO 13485 and quality management systems. • Six Sigma methodologies. • CAPA investigations. • Business Central. • Electronics fault-finding to component level. If this sounds like ...

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 ...

layouts, assembly drawings, BOMs and work instructions. A good understanding of electronics manufacturing quality standards and processes . Ideally, experience working within an ISO 9001 and/or ISO 13485 environment. Excellent attention to detail and good manual dexterity when handling small electronic components. Basic ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

service for assistive technology users. You’ll coach and develop technical staff, diagnose faults, collaborate with Hardware Engineering to improve product reliability, and drive ISO 13485 readiness and regulatory compliance across the #J-18808-Ljbffr ...

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 ...