Quality Assurance Specialist – Design & Development (Electronics)Hybrid,Oxford, UK | Oxford Nanopore Technologies
Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop and manufacture market-leading nanopore-based next generation sequencing (NGS) technologies used across research, biopharma, and in‑vitro diagnostics (IVD). Designed and manufactured in Oxford and used globally, our products operate within regulated environments supported by ISO 13485 and ISO 9001 Quality Management Systems.
We are seeking a Quality Assurance Specialist – Design & Development to support quality activities across the development lifecycle of our electronic products. Reporting to the QA Manager – NPI, this role ensures design control, risk management, and development processes are compliant and that products meet performance, safety, and regulatory requirements through to transfer into production.
You will collaborate closely with teams across R&D, technical transfer, manufacturing, product management, and regulatory affairs to support compliant product development and lifecycle management.
Key Responsibilities
- Support QA activities across design and development processes
- Review and approve Design & Development and Change Control documentation
- Ensure compliance with design controls, verification & validation (V&V), and traceability
- Participate in risk management and regulatory collaboration
- Support lifecycle design changes and verification/validation planning
- Maintain Quality System documentation, CAPA, and quality metrics
- Provide guidance on Document Management Systems and quality processes
- Support continuous improvement, training, and management reviews
Essential Qualifications & Experience
- BSc in Engineering or Science (e.g., electronics, microelectronics, electro‑mechanical engineering) or equivalent experience
- ~5 years’ experience in product design/development or QA within a regulated environment (ISO 9001 or ISO 13485)
- Experience supporting electronic product development
- Strong understanding of design control principles, including requirements, verification, validation, and risk management
- Working knowledge of document control, change management, non‑conformance, and CAPA systems
- Familiarity with relevant technical standards (IEC, ISO, ASTM)
Desirable
- ISO 9001 or ISO 13485 Internal Auditor training
- Experience within medical device or IVD environments
- Knowledge of statistical, process, or computer systems validation
- Experience authoring requirements, test protocols, or verification reports
What We’re Looking For
- Detail‑oriented with a strong quality mindset
- Strong problem‑solving and root cause analysis skills
- Comfortable working in a fast‑paced, collaborative environment
- Proactive with a continuous improvement mindset
Please note that no terminology in this advert is intended to discriminate on the grounds of a person’s gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.
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