Software Design QA Lead

Department: Engineering

Location: Berlin, Stockholm

Employment Type: FullTime

Mission

Neko Health exists to shift healthcare from treating illness to preventing it, using advanced, non‑invasive technology and clinical expertise to deliver early, actionable health insights.

Role Purpose

As a Software QA Engineering Lead, you will ensure the quality, safety, and regulatory compliance of our Software as a Medical Device (SaMD) and emerging AI-enabled healthcare products.

You will work closely with software engineers, DevOps teams, product development teams, the Verification & Validation function, and regulatory stakeholders to ensure software meets quality and regulatory standards while enabling fast and efficient development cycles.

This role is an individual contributor position focused on embedding quality practices directly into software development processes. You will contribute to shaping modern QA approaches that prioritize automation, integrated documentation, and efficient quality workflows rather than traditional documentation-heavy processes.

Your work will help ensure that Neko Health continues to build safe, compliant, and high-quality health technology while maintaining the agility required in a fast-moving healthtech environment.

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

· Establish strong collaboration with engineering and product teams to embed quality practices into development workflows.

· Collaborate with the V&V function to support verification and validation activities for Software as a Medical Device (SaMD), ensuring alignment with regulatory requirements.

· Support risk management and compliance activities related to software systems and AI-enabled features.

· Improve QA workflows by introducing automation, tooling, and AI-assisted processes that increase efficiency and reduce manual work.

· Identify opportunities to strengthen quality systems and continuously improve development and testing processes.

· Provide clear communication on quality risks, progress, and issues, ensuring effective collaboration with stakeholders.

Minimum Qualifications

· Experience working in Software Quality Assurance within regulated environments such as medical devices, healthtech, or digital health.

· Experience working with Software as a Medical Device (SaMD) or other regulated healthcare software products.

· Strong understanding of software development processes, testing strategies, and development pipelines.

· Experience collaborating closely with software engineers and cross-functional product teams.

· Ability to work independently and take ownership of QA activities in a fast-moving environment.

· Strong communication skills with the ability to clearly communicate risks, issues, and progress.

· Comfortable using AI tools and automation to improve workflows and productivity. · Fluent written and spoken English.

Preferred

· Experience working in healthtech startups, digital health platforms, or software-first medtech companies.

· Familiarity with regulatory frameworks such as IEC 62304, ISO 13485, ISO 14971, MDR, or FDA requirements.

· Experience working with DevOps environments, CI/CD pipelines, and automated testing frameworks.

· Experience supporting software products that incorporate AI or machine learning components.

· Hands-on experience improving workflows through automation, scripting, or tooling. · 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.