Quality Engineer – Microfluidics & Chemistry
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT are global leaders in nanopore-based next generation sequencing technology, delivering innovative research and IVD products worldwide.
We are seeking a Quality Engineer – Microfluidics & Chemistry to support our flow cell and chemistry product portfolio, ensuring robust quality and compliance across design, development, and production transfer.
The Role
Duties include, but are not limited to:
1. Support design control activities across microfluidic systems, flow cells and chemical/reagent products
2. Ensure compliance with ISO 9001 / ISO 13485 and internal Quality Systems
3. Review and approve Design & Development and Change Control documentation
4. Support Verification & Validation (V&V) planning, execution and traceability
5. Partner with R&D, Manufacturing, Technical Transfer and Regulatory Affairs
6. Contribute to risk management, CAPA and non-conformance activities
7. Support lifecycle design changes and technical impact assessments
You will have authority to review and approve relevant D&D processes and records.
About You
Essential:
8. BSc in Engineering, Chemistry or relevant Scientific discipline (or equivalent experience)
9. 5 plus years’ experience in Design/Development or QA within an ISO 9001 or ISO 13485 regulated environment
10. Strong understanding of design controls, V&V, risk management and traceability
11. Experience with microfluidics, reagent/chemical products, biological components or similar technologies
12. Working knowledge of DMS, Change Control and CAPA systems
Desirable:
13. Medical device or IVD experience
14. ISO 9001 / ISO 13485 Internal Auditor training
15. Validation experience (statistical, process or computer systems validation)
Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics globally.