QA Engineering 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

• Build out the AI instruction and infrastructure layer, including agent skills, instruction libraries, and tool integrations.
• Establish controls and guardrails for AI-enabled tools, ensuring access, validation, traceability, and audit trails.
• Translate existing QMS procedures into AI-assisted ways of working to reduce manual effort.
• Partner with Regulatory Affairs, DevEx, and Corporate Engineering to set standards for AI tool validation and maintenance.
• Support verification, validation, and test automation through AI-assisted approaches.
• Provide clear communication on quality and compliance risks and the impact of AI enablement.

Requirements

• At least 5 years in QA, RA, or Engineering within medical devices
• Understanding of Quality Management Systems (QMS) in regulated environments
• Hands-on experience with systems administration and quality systems configuration
• Strong expertise in QMS automation, tooling, and system integrations
• Proficiency in AI-assisted workflows, including agentic tools, Claude Code, and MCP
• Strong communication skills to bridge regulatory needs and engineering practice
• Fluent written and spoken English

Preferred Qualifications

• Experience with verification, validation, and/or test automation
• Familiarity with regulatory frameworks (IEC 62304, ISO 13485, ISO 14971, MDR, or FDA)
• Knowledge of computer system validation approaches (e.g., GAMP 5 / CSA)
• Experience with DevOps, CI/CD pipelines, and scripting (Python, PowerShell)
• Experience building internal tooling or operationalizing procedures in fast-scaling organizations