Instrument Design QA Lead

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk.

Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.

In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised,

actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is

the norm, and where your work genuinely helps people live longer, healthier lives.

As the Instrument Design QA Lead, you will own the quality of Neko’s medical device hardware and firmware across a dedicated

product family (Skin, Heart, Tissue): that what we build is safe, that it performs as intended, and that we can show it, from

first design input through to design transfer. Regulatory compliance follows from getting that right; it is not the point of the

job.

You hold authority to approve or reject quality deliverables and to enforce design control procedures. The engineering teams build

and own their designs and their changes; your job is to make sure safety and quality are engineered in from the start rather than

demonstrated after the fact, and to say so plainly when they are not.

You will be part of a small, high-trust Quality team, working closely with hardware and firmware engineers, operations, and

regulatory leads across an expanding product portfolio.

• Quality assure design controls across the product lifecycle, reviewing and approving verification and validation plans and

results, and keeping design inputs, outputs and traceability coherent across the family.

• Lead design reviews and risk management for your product family, owning the ISO 14971 lifecycle from hazard identification

through residual risk evaluation and benefit-risk analysis, with a pragmatic and engineering-driven approach.

• Facilitate and quality assure change management, with the engineering teams driving their own design and medical device changes

and you making sure each one is properly assessed, documented, reviewed and approved.

• Coordinate design transfer with Manufacturing QA and Production Engineering, moving designs into manufacturing with the

evidence and controls in place.

• Quality assure the technical documentation and medical device file for your product family, keeping them complete, current and

audit-ready under EU MDR and the FDA QMSR.

• Lead continuous improvement, using modern QA tooling, AI-assisted documentation and automated testing to raise quality and

development speed together.

• Deep expertise in design controls and risk management, with hands-on experience of EU MDR (2017/745), ISO 13485, ISO 14971, and

FDA 21 CFR Part 820 / Part 11.

• Systems engineering mindset, able to connect and coherently address hardware, firmware, and systems integration across a

product family.

• Genuine fluency with AI-driven workflows and modern digital tooling: eQMS, automation, and AI-assisted documentation are part

of how you work, not add-ons.

You will own quality for a product family that goes into real clinics and produces real health data for real people. The team is

small enough that your judgement carries, and close enough to engineering that you see the effect of it.