Description 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. LI-LH1 LI-hybrid What We’re Looking For Essential Qualifications & Experience: B.Sc. Degree in a relevant engineering or science discipline (e.g. relating to electronics, microelectronics or electro-mechanical engineering etc.) or equivalent relevant experience. 5 years’ previous experience working in a design or development function or within a quality assurance role focusing on design and development within a regulated (ISO 9001 or ISO 13485) firm. This experience must cover key aspects related to design and development of electronic products (ideally electronic devices used in laboratory applications or IVD applications). Consequent understanding of QA principles (focused particularly on the design and development process) and good industry practices within a regulated design and development function. Experience with and competence in the concepts of design inputs (requirements), design outputs, verification, validation, planning and reporting and risk management. Awareness and understanding of some relevant technical standards (ASTM, IEC, ISO etc.) is required. Consequent working knowledge of Document Management Systems, Change Control, non-conformity and CAPA systems. Desirable: ISO 9001 or ISO 13485 Internal auditor or similar industry training courses demonstrating familiarity with either or both of these standards. Experience of working in a medical device or IVD environment is a plus. Understanding of statistical validation, or process validation or computer systems validation is a strong want. Experience of authoring (any of the following) design inputs, outputs, test protocols and test reports is a strong want. Knowledge/skills/abilities Quality System Requirements. Working knowledge of ISO 9001 at least focused around design and development. Quality-focused and results-oriented. Ability to identify root cause of problem and creatively problem solve to gain resolution. Attention to detail. Familiar with Continuous Improvement methodologies. Working knowledge of ISO 13485 is advantageous. Understanding or experience with Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice is advantageous. Personal Attributes: Ability to adapt to constant change and influence positive change effectively. Positive attitude. Team –orientated and responsive to customer needs. Ability to work independently in fast-paced environment with little supervision.