QA Engineer – Software Development
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT) are global leaders in nanopore-based next generation sequencing technology, developing innovative research and IVD products used worldwide.
We’re looking for a QA Engineer – Software Development to support design control activities across flow cells, chemical components and reagent-based products, ensuring compliant development through to production transfer.
The Role
Duties include, but are not limited to:
1. Support design planning, requirements traceability and documentation review
2. Oversee Verification & Validation (V&V) planning and execution
3. Partner with R&D, Technical Transfer, Manufacturing and Regulatory Affairs
4. Contribute to risk management activities
5. Review and approve Design & Development and Change Control documentation
6. Support CAPA, non-conformance and Quality System processes
7. Ensure compliance with ISO 9001 / ISO 13485, GMP, GLP and GDP
You will have authority to review and approve D&D processes and records.
About You
Essential:
8. BSc in Engineering or relevant Scientific discipline (or equivalent experience)
9. 5+ years’ experience in Design/Development or QA within an ISO 9001 / ISO 13485 regulated environment
10. Strong understanding of design controls, V&V, risk management and traceability
11. Experience with design and development of software and firmware products, including software product lifecycle management.
12. Working knowledge of DMS, Change Control and CAPA systems
Desirable:
13. Medical device or IVD experience
14. Internal Auditor training (ISO 9001/13485)
15. Validation experience (statistical, process or CSV)
Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics worldwide.