Job description

Responsibilities: - Develop and maintain eQMS workflows, ensuring regulatory compliance. - Automate quality system procedures using Python, PowerShell, or Bash to reduce manual effort. - Integrate eQMS with enterprise tools (e.g., Jira, Azure DevOps, ERP, PLM) via RESTful APIs. - Build automated testing and validation for eQMS configurations to ensure compliance. - Implement GitHub Actions or Azure DevOps Pipelines for automation workflows. - Deploy real-time dashboards and reporting for compliance tracking and quality metrics. - Design practical notifications and alerts to reduce lead time and content switching. - Lead system validation efforts, ensuring CSV (Computer System Validation) compliance. - Maintain audit trails, data integrity, and access controls for regulatory compliance. - Support internal and external audits, ensuring seamless documentation and compliance. - Manage Cloud & Infrastructure Automation in Azure, AWS, or GCP for hosting and optimizing quality data tools. Requirements: - 5+ years of experience in DevOps QA, QMS automation, or regulated system management within the medical device industry. - Proficient in Python, PowerShell, or Bash for workflow automation and scripting. - Experience with API development and system integrations for enterprise tools. - Hands-on experience with GitHub Actions, Azure DevOps Pipelines, or similar CI/CD tools. - Familiarity with Cloud & Infrastructure Automation (Azure, AWS, or GCP) for quality data management. - Strong problem-solving skills and a process optimization mindset. - Excellent written and verbal communication skills in English. Nice to Have - Experience or knowledge of ISO 13485, FDA QSR (21 CFR 820), and EU MDR in digital environments. - Experience with AI/ML-driven automation. - Knowledge of cybersecurity and data integrity in regulated environments. Why Join Us? - At Neko Health, you'llshape the future of digital QMS automation, ensuring compliance while enabling seamless workflows and efficiency. - If you’re passionate about eQMS automation, DevOps, and cloud-based quality solutions, we’d love to hear from you!

Requirements