As a Software Design QA Lead, you'll play a key role in ensuring the reliability, safety, and regulatory adherence of AI-powered healthcare software. You'll work hand-in-hand with engineering and product teams to integrate robust quality assurance practices into agile development cycles, focusing on Software as a Medical Device (SaMD) solutions.
Key Responsibilities
- Partner with development and product teams to embed quality assurance throughout the software lifecycle.
- Support verification and validation processes in alignment with medical device regulations, collaborating closely with V&V specialists.
- Contribute to risk assessments and compliance efforts for software systems, particularly those involving AI components.
- Enhance QA efficiency by implementing automation, AI-assisted tools, and modern testing frameworks.
- Identify and drive improvements in quality systems, testing methodologies, and development workflows.
- Communicate quality status, risks, and progress clearly to technical and non-technical stakeholders.
What We’re Looking For
- Proven experience in QA within regulated domains such as medical devices, digital health, or healthtech.
- Direct experience with SaMD or similar regulated software products.
- Solid grasp of software development pipelines, testing strategies, and quality engineering principles.
- Ability to operate independently and lead QA initiatives in a fast-paced, evolving environment.
- Strong written and verbal communication skills, especially when explaining technical risks.
- Experience using AI and automation tools to streamline QA processes.
- Fluency in English, both written and spoken.
Preferred Background
- Experience in healthtech startups or software-centric medtech organizations.
- Familiarity with standards like IEC 62304, ISO 13485, ISO 14971, MDR, or FDA guidelines.
- Hands-on work with CI/CD pipelines, DevOps practices, and automated testing frameworks.
- Exposure to AI/ML-based software products and their validation challenges.
- Track record of optimizing workflows using scripting, automation, or tool development.
- Experience scaling QA processes in rapidly growing technology environments.
