Senior Quality Engineer - DevOps

About the Role

Join Neko Health, a pioneering health-tech company, to drive the automation, compliance, and integration of our electronic Quality Management System (eQMS) using modern DevOps practices.

Responsibilities

• Develop and maintain eQMS workflows, ensuring strict adherence to regulatory compliance standards.
• Automate quality system procedures using scripting languages like Python, PowerShell, or Bash to significantly reduce manual effort.
• Integrate the eQMS platform with enterprise tools (e.g., Jira, Azure DevOps, ERP, PLM) via RESTful APIs.
• Build robust automated testing and validation frameworks specifically for eQMS configurations to guarantee compliance.
• Implement automation workflows using CI/CD tools such as GitHub Actions or Azure DevOps Pipelines.
• Design and deploy real-time dashboards and reporting mechanisms for proactive compliance tracking and quality metrics monitoring.
• Lead Computer System Validation (CSV) efforts to ensure all systems meet regulatory validation requirements.
• Manage Cloud & Infrastructure Automation within Azure, AWS, or GCP to host and optimize quality data tools.

Requirements

• Minimum of 5 years of experience in DevOps QA, QMS automation, or regulated system management, preferably within the medical device industry.
• Proficiency in scripting for workflow automation using Python, PowerShell, or Bash.
• Proven experience with API development and integrating disparate enterprise systems.
• Hands-on experience configuring and managing CI/CD pipelines using GitHub Actions, Azure DevOps Pipelines, or similar platforms.
• Familiarity with Cloud & Infrastructure Automation tools (Azure, AWS, or GCP) as applied to quality data management.
• Excellent written and verbal communication skills in English.

Nice-to-Haves

• Direct experience or knowledge of key regulatory frameworks including ISO 13485, FDA QSR (21 CFR 820), and EU MDR in digital environments.
• Exposure to AI/ML-driven automation techniques.
• Understanding of cybersecurity principles and data integrity requirements within regulated quality systems.