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- Tasks: Support quality assurance activities in the design and development of innovative electronic products.
- Company: Join Oxford Nanopore Technologies, a leader in next-generation sequencing technologies.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on cutting-edge technology that shapes the future of diagnostics.
- Qualifications: BSc in Engineering or Science with 5 years' experience in QA or product development.
- Other info: Collaborative environment focused on continuous improvement and innovation.
The predicted salary is between 36000 - 60000 £ per year.
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.
Quality Assurance Specialist in Oxford employer: Oxford Nanopore Technologies Ltd.
Contact Detail:
Oxford Nanopore Technologies Ltd. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist in Oxford
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their quality assurance processes and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your answers to common interview questions, especially those related to design control and risk management. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Oxford Nanopore Technologies.
We think you need these skills to ace Quality Assurance Specialist in Oxford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experience mentioned in the job description. Highlight your background in quality assurance and any relevant projects you've worked on, especially in regulated environments like ISO 9001 or ISO 13485.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for the Quality Assurance Specialist role. Share specific examples of how you've supported product development and compliance in the past, and don’t forget to show your enthusiasm for working with cutting-edge technology!
Showcase Your Problem-Solving Skills: In your application, emphasise your strong problem-solving abilities and detail-oriented mindset. We want to see how you've tackled challenges in previous roles, particularly in design control and risk management.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re proactive and keen to join our team!
How to prepare for a job interview at Oxford Nanopore Technologies Ltd.
✨Know Your Quality Standards
Familiarise yourself with ISO 13485 and ISO 9001 standards, as these are crucial for the role. Be ready to discuss how you've applied these standards in your previous work, especially in design control and risk management.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled quality issues in past projects. Highlight your root cause analysis skills and how you implemented solutions that improved product quality or compliance.
✨Understand the Product Lifecycle
Brush up on the development lifecycle of electronic products. Be prepared to discuss how you’ve supported QA activities throughout this process, from design to production, and how you ensure compliance at each stage.
✨Collaborate and Communicate
Since the role involves working closely with various teams, think of examples where you've successfully collaborated with R&D, manufacturing, or regulatory affairs. Emphasise your communication skills and how they helped in achieving project goals.