Software Design QA Lead

About the Company

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission is to make data-driven, preventative care accessible to more people, before symptoms appear.

Responsibilities

• 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)
• 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
• Identify opportunities to strengthen quality systems and continuously improve development and testing processes
• Provide clear communication on quality risks, progress, and issues to stakeholders

Requirements

• Experience in Software Quality Assurance within regulated environments (medical devices, healthtech, or digital health)
• Experience working with Software as a Medical Device (SaMD) or regulated healthcare software
• Strong understanding of software development processes, testing strategies, and development pipelines
• Experience collaborating with software engineers and cross-functional product teams
• Ability to work independently and take ownership of QA activities
• Strong communication skills regarding risks and progress
• Proficiency with AI tools and automation to improve workflows
• Fluent written and spoken English

Preferred Qualifications

• Experience in healthtech startups or software-first medtech companies
• Familiarity with regulatory frameworks such as IEC 62304, ISO 13485, ISO 14971, MDR, or FDA
• Experience with DevOps environments, CI/CD pipelines, and automated testing frameworks
• Experience supporting software products incorporating AI or machine learning
• Hands-on experience improving workflows through automation, scripting, or tooling