Quality & Operations Specialist
Luma Eye Tracker is an advanced eye-tracking solution used in vision diagnostics and occupational services. As we grow, we’re looking for someone who will help us keep things organised, well-documented, and aligned with medical device requirements – while also supporting day-to-day administrative and coordination tasks. This role is a mix of quality, compliance, and structured admin work, so it’s perfect for someone who enjoys keeping things in order and making sure nothing falls through the cracks.
Your Role
- Keep our documentation organised, up to date, and easy to navigate.
- Lead the preparation and maintenance of documents related to compliance, quality, and product development.
- Take ownership of the MDR certification process internally, driving activities, timelines, and documentation readiness across the company.
- Coordinate across teams (technical, clinical, product) to gather, structure, and maintain all required MDR and ISO documentation.
- Act as the central point of contact for MDR and ISO standards, ensuring alignment with requirements and internal processes.
- Prepare and organise materials for audits and external reviews, ensuring everything is complete, structured, and submission-ready.
- Track changes, updates, and feedback to ensure full traceability and compliance.
- Support and structure post-market surveillance activities, including collection and organisation of product data and feedback.
- Identify gaps in documentation or processes and proactively drive improvements.
- Contribute to building and refining internal quality management workflows.
What We Are Looking For
- Highly organised, detail-oriented, and reliable individual.
- Structured thinker who values clarity, compliance, and well-maintained documentation systems.
- Comfortable working with documents, spreadsheets, and digital collaboration tools.
- Strong communication skills with the ability to coordinate across multiple teams and stakeholders.
- Ability to independently drive MDR certification activities and take ownership of regulatory processes.
- Familiarity with MDR requirements and ISO standards (e.g. ISO 13485) or strong motivation to quickly build expertise.
- Proactive mindset – able to identify gaps, inconsistencies, or risks and act on them.
- Fluency in English (written and spoken).
- Interest in healthcare, medical devices, or regulated environments.
- Previous experience in quality, regulatory, or similar roles is a strong advantage.
Qualifications & Knowledge
- Understanding of Quality Assurance processes and Quality Control techniques.
- Familiarity with Quality Management Systems and structured documentation practices.
- Knowledge of MDR regulations and relevant ISO standards (especially ISO 13485).
- Understanding of Good Manufacturing Practice (GMP) guidelines.
- Strong organisational, problem-solving, and analytical skills.
- Collaborative mindset with the ability to work across multidisciplinary teams.
- Background in healthcare, medical devices, or technology is an advantage.
- A bachelor’s degree in Quality Management, Engineering, Life Sciences, or a related field is preferred.
What We Offer
- Flexible working hours, hybrid work setup.
- Competitive salary with a KPI-based bonus structure.
- A supportive, international team where you can learn and grow.
- Employment options: part-time (PT), full-time (FT), or on a contractual basis.
- Hands-on experience in a fast-growing digital health company.
- Opportunity to gradually learn about medical device compliance without pressure.
- Real impact on how the company stays organised and operates day to day.
