Senior Quality & Safety Engineer
Oxford (On-site)
Operations – Facilities /
Full-Time /
On-site
Join ONI and Explore the Boundaries of Scientific Discovery!
At ONI, we are driven by a profound mission: to propel scientific discovery and combat diseases by granting everyone the ability to visualize, comprehend, and share the intricate microscopic details of life. Our revolutionary Nanoimager stands at the forefront of advancing cellular studies on a molecular level, making substantial contributions to the evolution of scientific knowledge
We are seeking a Senior Quality Systems & Safety Engineer to build and scale quality systems and product safety practices for UK-based manufacturing of super-resolution microscopy platforms, workflows, and consumables.
This role is ideal for someone who thrives in early-stage scale-up environments, where quality systems must be right-sized, risk-based, and operationally practical, while still supporting future UKCA, CE, and global regulatory pathways.
You will act as both a builder and owner of quality and safety infrastructure as products transition from prototype to repeatable production.
Key Responsibilities
- Maintain & Scale the Quality Management System
- Design, implement, and scale a fit-for-purpose QMS for an early-stage UK manufacturing operation aligned with:
- ISO 9001 (and ISO 13485 where strategically appropriate)
- UKCA and CE marking readiness
- Define and implement core QMS processes, prioritising:
- Document and record control
- Change management (ECO/ECR)
- Nonconformance and CAPA
- Training and competency
- Ensure systems are lean, digital, and scalable, avoiding over-engineering.
- Lead product safety engineering for super-resolution microscopy systems manufactured in the UK, including:
- Laser and optical safety
- Electrical and mechanical hazards
- Software-controlled workflows
- Chemical and biological risks from consumables
- Perform and maintain:
- Hazard analyses and risk assessments (FMEA, hazard analysis)
- Safety files and technical documentation
- Input to UKCA / CE Declarations of Conformity
- Embed risk-based decision making into daily engineering and manufacturing activities.
- Partner closely with R&D to support design transfer from prototype to production, ensuring:
- Manufacturability and serviceability
- Safety and compliance readiness
- Clear design outputs and acceptance criteria
- Support establishment of:
- Assembly and test processes
- Incoming, in-process, and final inspection strategies
- Early process capability and yield tracking
Product Safety & Risk Management
Design Transfer & Manufacturing Readiness
Requirements
- Bachelor’s degree in Engineering, Physics, Life Sciences, or related field
- 7–10+ years’ experience in quality systems, product safety, or manufacturing quality
- Proven experience in early-stage manufacturing or scale-up environments
- Strong working knowledge of:
- ISO 9001 (ISO 13485 a plus)
- Risk management and product safety standards
- UKCA / CE fundamentals for laboratory equipment
- Comfortable operating hands-on in manufacturing and engineering spaces
At ONI, we understand that a fulfilling career involves more than just challenging work - it's about enjoying a well-rounded experience. When you become a part of our team, you not only contribute to groundbreaking research but also enjoy a range of benefits designed to enhance your life both inside and outside the workplace.
As an equal opportunity employer, we prioritize fairness and respect, ensuring every team member thrives regardless of their background. But that's not all - our perks include:
💰 Competitive Compensation We recognise and reward your talent. Enjoy a competitive salary that reflects your expertise and contributions, ensuring your hard work is recognized.
🌴 Time Off That Counts 28 days of annual leave plus bank holidays and 4 dedicated wellbeing days!
💪 Onsite Gym Facilities Stay active and energized with our convenient onsite gym, promoting your overall health.
🩺 Private Healthcare and Dental Coverage Your health matters to us. Access top-notch medical and dental services, ensuring your well-being is in good hands.
🤝 Inclusive Culture Be a valued member of our diverse, inclusive family. Your unique perspective is celebrated here, fostering a culture of mutual respect and understanding.
🧠 Health Assured Your mental health is essential. Access our comprehensive mental health support services for a balanced work-life experience.
🏦 People’s Pension Secure your future with our pension scheme, investing in your financial well-being beyond the workplace.
🎁 Perks at Work Enjoy exclusive discounts and deals through our perks at work program, adding value to your everyday life.
If you are driven by innovation, eager to make a significant impact in the realm of scientific and medical research, and possess the skills and passion we are looking for, we invite you to apply and be a part of our mission to improve our understanding of the details of life.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
