Software Design QA Lead
Neko Health
full-time
Posted on:
Location Type: Hybrid
Location: Berlin • Germany
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Job Level
About the role
- Establish strong collaboration with engineering and product teams to embed quality practices into development workflows.
- Define and support verification and validation strategies 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.
Requirements
- 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.
- Experience working in healthtech startups, digital health platforms, or software-first medtech companies (preferred).
- Familiarity with regulatory frameworks such as IEC 62304, ISO 13485, ISO 14971, MDR, or FDA requirements (preferred).
- Experience working with DevOps environments, CI/CD pipelines, and automated testing frameworks (preferred).
- Experience supporting software products that incorporate AI or machine learning components (preferred).
- Hands-on experience improving workflows through automation, scripting, or tooling (preferred).
- Experience working in fast-scaling organizations with evolving processes (preferred).
Benefits
- Equal Opportunity & Inclusion Statement
- Commitment to inclusive hiring and member-first care.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Software Quality Assuranceverification and validation strategiesrisk managementcompliance activitiesautomationtesting strategiesCI/CD pipelinesautomated testing frameworksscriptingAI-enabled features
Soft Skills
collaborationcommunicationindependenceownershipproblem-solvingadaptabilitystakeholder engagementcontinuous improvementefficiency enhancementclear communication
Certifications
IEC 62304ISO 13485ISO 14971MDRFDA requirements