Act as a hands‑on QA/RA partner helping maintain and improve iLoF’s ISO 13485 Quality Management System across R&D, clinical, and operations.
Draft, review, and update SOPs, work instructions, and forms; ensure document control, change control, training records, and audit trails are compliant and inspection‑ready.
Lead and/or support internal audits and supplier audits; coordinate CAPA/NC workflow from root‑cause analysis to effectiveness checks.
Guide risk management activities per ISO 14971 (hazard analysis, risk file maintenance, benefit‑risk, traceability to design/verification/clinical evidence).
Support IVDR (EU 2017/746) compliance: device/assay classification, performance evaluation (PEP/PEP report), analytical/clinical evidence mapping, PMS/PMPF planning.
Contribute to technical documentation (GSPRs, device description/IFU, labeling, usability inputs per IEC 62366‑1, manufacturing & QC records, verification/validation summaries).
Prepare and maintain audit/inspection readiness (TMF/QMS records, checklists, mock audits) and liaise with Notified Bodies/regulators when needed.
Advise on best‑practice design and development controls, verification/validation plans, and data integrity across lab, software, and clinical interfaces.
Coach teams on QA/RA principles; deliver targeted training and help embed a quality culture in a fast‑moving startup.
Set up pragmatic metrics & dashboards for QMS health (e.g., CAPA cycle‑time, training completion, audit findings, doc control SLAs).

Engagement: part‑time. Location: Portugal (Hybrid), with occasional on‑site visits.

Qualifications

Technical Skills ✔️

2+ years QA/RA experience in medical devices/IVD, including hands‑on ISO 13485 QMS ownership and audit exposure.
Strong knowledge of IVDR (classification, performance evaluation, PMS/PMCF/PMPF) and ISO 14971 risk management.
Demonstrated ability to write clear, auditable SOPs, manage doc control, and run CAPA/NC investigations to closure.
Experience preparing/maintaining technical documentation and interfacing with Notified Bodies.
Familiarity with IEC 62366‑1 (usability), IEC 62304 (if software is in scope), and good laboratory documentation practices.
Nice to have: exposure to 21 CFR 820/QMSR alignment, and QMS tools.

Cultural Skills ✔️

Practical, low‑ego problem solver who can balance regulatory rigor with startup agility.
Clear communicator who can translate requirements for scientists, engineers, and leadership.
Ownership mindset; proactive and comfortable working autonomously.

Nice to Have

Internal/Lead Auditor certification (ISO 13485/ISO 9001).
Experience with optics/photonics workflows or AI‑enabled digital health environments.

Stuff you want to know

Contract type: Part‑time contractor.

Additional Information

iLoF in a nutshell 💡

As personalized medicine becomes the norm, scientists, patients, and healthcare systems worldwide face massive barriers in providing the right treatment to the right patient.

Recognized by CB Insights and Financial Times as one of the most promising Digital Health companies in the world, iLoF is building an AI-powered platform capable of transforming precision medicine.

Our goal is to become the platform that democratizes access to personalized medicine for millions of people living with complex diseases around the globe.

Thanks to our proprietary optical fingerprint library of disease biomarkers and biological profiles we can offer personalized patient screening and stratification in a faster and more affordable way, saving up to 40% of the cost and 70% of the time while enabling a more human patient experience.

Supported by leading institutions like Microsoft Ventures, Mayfield, and the Oxford University, iLoF is currently focusing on validating its platform technology in one of the biggest challenges of our times: Alzheimer's, while maintaining ongoing verticals on Digestive Cancer, Stroke, and Infectious diseases.

Our Team 🧑🏻‍💻

We are a mix of scientists, entrepreneurs, and inventors based in Oxford and Porto, with a passion for healthcare!

Recognized by CB Insights as one of the most promising Digital Health companies in the world and by the Financial Times as a Transformational Business in Healthcare, iLoF has been regularly featured in leading outlets like Tech Crunch, Wired, and Sifted and listed as a rising star in AI-Driven Drug Discovery, Health Screening & Data Analytics.

What we value

A Be Kind attitude is the main guideline within iLoF
A hand in the hammer and another free to support your co-workers as a true team player
An honest and egoless attitude towards discussions and critics working in good faith
The braveness to speak your heart in any situation
Through words or actions be always sure to make a difference at any moment!
Be proud to drive your responsibilities to success and help others do the same, embracing ownership!

Perks 😉

An exciting future with a deep-tech company selected by Financial Times and CB Insights as one of the most transformative companies in the world
A high‑paced, flexible environment: adaptable working hours, strong remote work culture
A stimulating atmosphere with room for creativity – fast‑paced, fun, and energetic start‑up with a friendly culture
Weekly happy hours with amazing food and drinks
Free coffee and snacks ☕
Private healthcare insurance (for employees; contractor benefits to be agreed)
The opportunity to work with a world‑class, talented team – and potentially change healthcare as we know it for millions of patients living with complex diseases around the globe 🧑‍⚕️

We share a passion for being part of a mission that matters, and we are always looking for curious and collaborative people who share our values and want to be part of our journey.

If that sounds like a fit for you, click the apply button and join us.

You’ve read all this way but you’re missing a skill or two? No problem, it’s our job to upskill you to take your career to the next level. What we’re trying to say is, don’t be afraid to apply if you don’t tick all the boxes.

Apply now

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