4 of 4 ISO 13485 Jobs in the Thames Valley

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 … 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. … highly desired. Understanding or experience of computer systems validation is desirable (e.g. GAMP5). Knowledge/Skills/Abilities Essential: Detailed working knowledge of ISO13485, MDSAP requirements and the IVDR are essential. Demonstrable experience of working with external partners and stakeholders, showing a balanced level of discretion and sensitivity to More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

the release process. Ensure compliance with regulatory or internal change management policies, including experience with standards surrounding software as a medical device, for example ISO 13485 and ISO 62304. Test Automation Maintain best practices for release management, such as CI/CD (Continuous Integration/Continuous Deployment More ❯

existing software in line with defined procedures. Ensure all activities undertaken are in compliance with company SOPs and Work Instructions and in accordance with ISO 13485 and CFR 820. Ensure the Service Desk Team Lead is made aware of key support issues and trends identified in the ITSM. More ❯