About this role
Senior Software Quality Engineer at Coringroup. Location: Cirencester, England, United Kingdom. Role: overseeing development, conducting audits, supporting compliance Requirements: Bachelor's degree, 5+ years QA experience in medical device software, knowledge of ISO 13485/14971/IEC 62304 and FDA software regulations, EM/SDLC compliance, auditing and cybersecurity experience preferred. Category: Quality Assurance Seniority: Senior Level Tools: ISO 13485, ISO 14971, IEC 62304, ISO 27001, ISO 42001, NIST Cybersecurity Framework, 21 CFR Part 820, 21 CFR Part 11, FDA Pre-Market and Post-Market Cybersecurity Guidance Certifications: trained internal quality system auditor, software quality auditor, mdsap Commitment: Full Time Workplace: Hybrid Languages: English