2 of 2 DemandTrendPermanent ISO 13485 Jobs in Surrey

engineering governance activities, including Critical Design Reviews (CDRs). Collaborate with verification and validation teams to support defect triage and resolution. Monitor regulatory standards, ensuring compliance with IEC 60601, ISO 14971, and other relevant frameworks. Conduct risk management activities, including FMEA, hazard analysis, and early-phase risk reviews. Provide technical input, risk assessments, and continuous improvement recommendations during project … s degree (or equivalent) in Biomedical, Mechanical, Electrical, Systems Engineering, or related discipline. Proven problem-solving skills in high-reliability, life-supporting systems (e.g., ventilators). Demonstrated experience applying ISO 14971 risk management to medical device development. Strong knowledge of IEC 60601-1 standards for safety and performance in medical systems. Background in systems engineering disciplines: requirements management, architecture … V&V, and release. Proficiency in requirements engineering and risk analysis techniques across the device lifecycle. Strong understanding of ISO/IEC/IEEE 15288 systems engineering lifecycle within regulated environments. Experience working cross-functionally in multidisciplinary teams. Desirable Skills Experience in R&D within regulated industries, ideally under ISO 13485 and IEC 60601. Knowledge of real More ❯

Out: ? Real ownership of Quality & HSE systems ? Influence group-wide safety and compliance initiatives ? Collaborative, high-performing team ? Exceptional benefits and career development ?? Key Responsibilities: Accreditation & Compliance Maintain ISO9001, ISO13485, ISO18001, ISO14001, and ISO45001 standards Conduct internal and external audits Ensure REACH and ROHS compliance Manage CAPA and document control systems Quality Control Improve manufacturing quality controls to reduce defects … Were looking for someone with: Proven track record in a quality management role within electronics manufacturing or a similarly regulated industry Strong working knowledge of ISO standards (ISO9001, ISO13485, ISO14001, ISO45001) Proven experience in QMS development , Lean , and Continuous Improvement (CI) methodologies Familiarity with embedded systems , cables , touch screens , or electronic engineering Experience managing supplier quality , customer returns , and More ❯