2 of 2 Permanent ISO 9001 Jobs in Oxford

authorities. To ensure that products conform with relevant regulations in territories in which they are sold; OND and ONT operate two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT). Reporting and providing primary support to the Head of QA, the role of the Associate Director … QA (as directed) in any matter. • All activities required to help ensure the QA team achieve their annual objectives and maintain/sustain the ISO9001 & 13485 accreditation. This may require the role to fulfill part of the role of "Person with Responsibility for Regulatory Compliance" as per the EU IVDR. … include in-depth work with both complex instrumentation and IVD reagents and assays. Experience of working in an MDSAP-compliant environment. Experience of leading ISO 13485 certification audits. Detailed understanding of risk management, process validation, clinical validation and IVD performance evaluation requirements. Experience of working in an IVD environment More ❯

or computer hardware products - The ability to demonstrate successful management of multiple concurrent projects to time, cost and budget. - Experience of working to the ISO 9001 standard or a professional and process driven Methodology - Skilled in Microsoft Project (or similar tool) Gantt charting, task and resource planning. - Skilled More ❯