QA Engineering Lead

Neko Health; Stockholms kommun; On-site; SEK 600,000 - 800,000; Full time

Job summary

Neko Health, located in Stockholms län, seeks a QA Engineering Lead to enhance quality assurance through AI. You will design and implement AI-driven quality systems, ensuring compliance while improving workflow efficiency.

Your responsibilities include developing AI tools for quality processes, establishing regulatory controls, and collaborating with teams to translate quality management procedures into automated workflows. Candidates must have substantial experience in QA within medical devices and strong communication skills.

Qualifications

• At least 5 years of experience in QA, RA, or Engineering within medical devices.
• Understanding of quality management systems in regulated environments.
• Experience with automation, tooling, and system integrations.

Responsibilities

• Build AI instruction and infrastructure layer for quality procedures.
• Establish controls for AI-enabled tools in a regulated environment.
• Translate QMS procedures into AI-assisted workflows.

Skills

QA experience

Regulatory Affairs knowledge

Systems Administration

QMS automation

Fluent in English

Tools

Python

PowerShell

Job description

Mission

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.

Role Purpose

As a QA Engineering Lead, you will own the technical execution and engineering excellence of Neko's Quality Assurance function — building and maintaining the systems, tooling, and workflows that make quality processes effective, measurable, and scalable, and enabling the broader QA team to operate within them, working in partnership with DevEx and Corporate Engineering.

Your initial focus will be designing, building, and rolling out the AI enablement layer of our quality system — the instructions, agents, integrations, and controls that let teams work faster while staying compliant. This is hands‑on technical leadership — you'll set direction for how AI is used across quality while doing the build yourself, and what you build should get used across the function and meaningfully change how QMS-related work happens here.

You will design how AI tools are configured, governed, and validated so they can be trusted inside a regulated medical-device environment: turning quality procedures into AI-assisted workflows, and putting the guardrails in place that make their output reliable, traceable, and audit‑ready.

This role sits at the intersection of data, AI, and systems engineering on one side and quality, regulatory, and product safety on the other. You understand how a QMS operates and what it takes to work within a regulated environment, and you use that understanding to enable the rest of the organization rather than slow it down.

Your work will help ensure that Neko Health continues to build safe, compliant, and high-quality health technology while raising both the quality and the velocity of how we operate.

What You'll Deliver in the First 6–12 Months

• Build out the AI instruction and infrastructure layer — agent skills, instruction libraries, and tool integrations (e.g. MCP) — that operationalise our quality procedures into efficient, AI-assisted workflows.
• Establish the controls and guardrails for AI-enabled tools — access, validation, traceability, human-in-the-loop checkpoints, and audit trails — so their output can be trusted in a regulated environment.
• Translate existing QMS procedures into AI-assisted ways of working that reduce manual effort without compromising compliance.
• Partner with Regulatory Affairs, DevEx, and Corporate Engineering to set the standard for how AI tools are introduced, validated, and maintained, including tool/computer system validation where required.
• Support verification, validation, and test automation through AI-assisted approaches that increase coverage and efficiency.
• Provide clear communication on quality and compliance risks, and demonstrate the impact of AI enablement on both quality and velocity.
• Keep pace with AI developments and frameworks, and continuously improve our AI-assisted review — including context and memory engineering — so quality workflows stay effective as the tooling evolves.

Minimum Qualifications

• At least 5 years in QA, RA, or Engineering within medical devices.
• Understanding of how a quality management system operates and what it means to work within a regulated environment.
• Hands‑on experience with systems administration, quality systems, and role/access configuration.
• Strong on QMS automation, tooling, and system integrations.
• Fluent in AI-assisted ways of working — agentic tools, Claude Code, skills, and MCP — as a default mode of working, with the judgment to know which workflows suit AI.
• Strong communication skills, with the ability to translate between regulatory needs and engineering practice.
• Ability to work independently and take ownership in a fast-moving environment.
• Fluent written and spoken English.

Preferred

• Experience with verification, validation, and/or test automation.
• Familiarity with regulatory frameworks such as IEC 62304, ISO 13485, ISO 14971, MDR, or FDA requirements, and with computer system validation approaches (e.g. GAMP 5 / CSA).
• Experience with DevOps environments, CI/CD pipelines, and scripting (e.g. Python, PowerShell).
• Experience operationalizing procedures or building internal tooling and platforms.
• Experience working in fast-scaling organizations with evolving processes.

About titles at Neko

We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process.

Hiring Process

Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team.

Equal Opportunity & Inclusion Statement

Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.