Oxford Nanopore Technologies is seeking a Quality Engineer to support design control activities across flow cells, chemical components, and reagent-based products. You will ensure compliant development through to production transfer by partnering with R&D, Technical Transfer, Manufacturing, and Regulatory Affairs teams.
What You'll Do
- Support design planning, requirements traceability, and documentation review.
- Oversee Verification & Validation (V&V) planning and execution.
- Partner with R&D, Technical Transfer, Manufacturing, and Regulatory Affairs.
- Contribute to risk management activities.
- Review and approve Design & Development and Change Control documentation.
- Support CAPA, non-conformance, and Quality System processes.
- Ensure compliance with ISO 9001 / ISO 13485, GMP, GLP, and GDP.
- Review and approve D&D processes and records.
What We're Looking For
- BSc in Engineering or a relevant Scientific discipline, or equivalent experience.
- 5+ years’ experience in Design/Development or QA within an ISO 9001 / ISO 13485 regulated environment.
- Strong understanding of design controls, V&V, risk management, and traceability.
- Experience with design and development of software and firmware products, including software product lifecycle management.
- Working knowledge of DMS, Change Control, and CAPA systems.
Nice to Have
- Medical device or IVD experience.
- Internal Auditor training (ISO 9001/13485).
- Validation experience (statistical, process, or CSV).
Work Mode
This role operates on a hybrid basis from our Oxford, UK office.
Oxford Nanopore Technologies is an equal opportunity employer.
