About this role
Quality Engineer - Computer Systems Validation at Oxford Nanopore Technologies. Location: Oxford or Abingdon. Role: managing validation, ensuring compliance, supporting audits Requirements: B.Sc. (or equivalent) in CS/Engineering/Life Sciences, proven CSV experience in a GxP environment, knowledge of GAMP 5/21 CFR Part 11/EU Annex 11/ISO 13485, SDLC understanding, strong technical writing and audit support skills. Category: Engineering Seniority: Mid Level Tools: GAMP 5, 21 CFR Part 11, EU Annex 11, ISO 13485, GxP, eQMS, MES, CRM, ERP, Computer Software Assurance (CSA), ALCOA+, SDLC, CAPA Certifications: iso 9001, iso 13485 Commitment: Full Time Workplace: Hybrid Languages: English