Software Design QA Manager
Mission
At Neko Health, our mission is to deliver proactive healthcare for all—empowering members to take control of their health through cutting-edge technology and compassionate care.
Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Neko's vision is to shift healthcare from reactive treatment toward preventative health and early detection. This requires completely reimagining the patient's experience and incorporating the latest advances in sensors and AI. Neko Health has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is convenient and affordable for the public. The company is based in Stockholm, offering the Neko Body Scan experience at locations in Stockholm, London and Manchester, with over 500 employees.
About the role:
At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As Software Design QA Manager, you will drive quality assurance strategy and leadership in our software development domain, working in close partnership with our software engineering teams. You will own design control, risk management, regulatory compliance, and ensure audit-ready technical documentation and Design History Files (DHFs) while leading a growing team to deliver safe, timely, and compliant software product development across cloud-based and SaaS platforms. This is both a strategic and operational leadership role where you'll shape the future of our QA approach in software design and development. Working hand-in-hand with software engineering leaders, you'll balance the art of maintaining quality standards with enabling development velocity through AI-driven tools, automation, and DevOps practices. You'll bring an engineering mindset to quality, leveraging modern tooling and integrated solutions to drive efficiency while ensuring our organization moves cohesively towards shared goals and building a culture of quality excellence in software as a medical device (SaMD), health software, and AI/ML-enabled technologies.
Responsibilities
Drive the overall QA strategy and philosophy in the software lifecycle domain, setting the vision for quality excellence in SaMD, cloud-based health software, and AI/ML technologies.
Lead and develop a growing QA team with an engineering mindset, providing mentoring, coaching, and professional development to build software quality expertise.
Define and implement AI-driven QA processes and automated workflows that balance compliance rigor with agile development speed and DevOps efficiency.
Own design control and risk management strategies for software medical devices, ensuring compliance with IEC 62304, IEC 82304, EU MDR, and US FDA requirements for cloud and SaaS deployments.
Build and maintain audit-ready technical documentation, Software Design History Files (DHFs), risk files, and cybersecurity documentation using modern tooling and automation.
Ensure DevOps-integrated quality gates and continuous compliance monitoring across CI/CD pipelines for cloud-based medical device software.
Partner with software engineering leaders, cloud architects, and DevOps teams to drive quality outcomes across the entire software development lifecycle.
Lead the organization's preparation for audits and regulatory inspections, ensuring readiness and confidence.
Make strategic decisions on QA tooling, automation investments, staff planning, and team structure to support growing business needs.
Requirement
10+ years of experience in Software Design Quality roles within the medical device industry.
BSc or MSc in computer science, software engineering, biomedical engineering, or equivalent technical discipline.
Proven leadership experience building and scaling teams in high-growth environments.
Deep knowledge of IEC 62304, IEC 82304, ISO 14971, ISO 13485, and cybersecurity standards (IEC 81001-5-1, AAMI TIR57).
Strong understanding of EU MDR (2017/745) and US FDA (21 CFR Part 820, Part 11) requirements for cloud and SaaS environments.
Hands-on experience with Notified Body interactions and regulatory authority audits for software driven medical devices.
Proficient with modern DevOps practices, CI/CD pipelines, and automated testing frameworks.
Comfortable evaluating, selecting, and deploying modern QA tooling, automation platforms, and AI driven solutions.
Strategic thinker who balances risk, safety, development speed, and infrastructure costs. Strong communicator who thrives in cross-functional collaboration with software engineers, cloud architects, and DevOps teams.
Excellent written and verbal communication skills in English.
Nice to Have
Experience from successfully leading quality in fast-scaling companies with frequent organizational change and evolving priorities.
Deep knowledge of cloud platforms (AWS, Azure, GCP), containerization (Docker, Kubernetes), and infrastructure-as-code (Terraform).
Experience with AI/ML validation and verification methodologies for medical devices.
Swedish language skills.
Why Join Us?
At Neko Health, you'll lead the transformation of software quality assurance in medical device development, building world-class teams and AI-driven processes that enable breakthrough healthcare innovations powered by cloud platforms, automation, and modern engineering practices while maintaining the highest safety and compliance standards. If you're passionate about leading software quality excellence with an engineering mindset, leveraging AIdriven tools and automation to deliver business value, building high-performing teams, and shaping the future of cloud-native medical device development, we'd love to hear from you!
We offer a dynamic work environment with a high degree of autonomy that fosters growth and development. If you are passionate about building a better healthcare system for everyone and you thrive in a fast-paced environment, we would love to hear from you!
Please note: we perform background and reference checks as part of our interview 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.
