Senior Quality & Safety Engineer in Oxford

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.

• Build & 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 documentation and record control; change management (ECO/ECR); nonconformance and CAPA; training and competency. Ensure systems are lean, digital, and scalable, avoiding over-engineering.
• Product Safety & Risk Management: 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, and 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.
• Design Transfer & Manufacturing Readiness: 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, and early process capability and yield tracking.

• 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.

• Competitive Compensation – a competitive salary that reflects your expertise and contributions.
• 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.
• Private Healthcare and Dental Coverage – top-notch medical and dental services.
• Inclusive Culture – value and celebrate diverse perspectives.
• Health Assured – comprehensive mental health support services.
• People’s Pension – secure your future with our pension scheme.
• Perks at Work – exclusive discounts and deals through our perks at work program.

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. 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.