Quality Assurance Specialist - Electronics in Oxford

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.

• 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

• 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)

• 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

• 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.

About Us: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore‐based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.