Global Sales is hiring a Quality Assurance Specialist for Design & Development (Electronics). In this role, you will ensure design control, risk management, and development processes are compliant, and that our electronic products meet performance, safety, and regulatory requirements through to production transfer.
What You'll Do
- Support QA activities across all 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
What We're Looking For
- 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)
- Quality-focused and results-oriented mindset
- Ability to identify root cause of problems and creatively problem solve
- Strong attention to detail
- Familiarity with Continuous Improvement methodologies
Nice to Have
- 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
- Working knowledge of ISO 13485
- Understanding or experience with Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice
Team & Environment
You will report to the QA Manager – NPI and collaborate closely with teams across R&D, technical transfer, manufacturing, product management, and regulatory affairs.
Work Mode
This is a hybrid position based in Oxford, UK.
Our Culture: We are detail-oriented with a strong quality mindset. You'll need strong problem-solving and root cause analysis skills, comfort in a fast-paced, collaborative environment, and a proactive, continuous improvement mindset. We value a positive attitude, the ability to adapt to and influence constant change, and team orientation. You must be able to work independently in a fast-paced environment with little supervision.
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.
