Full-Time Senior Quality Engineer - DevOps

Neko Health is a Swedish health-tech company. We develop innovative medical technologies. As a Senior DevOps QA Engineer, you will drive automation, compliance, and integration within our electronic Quality Management System (eQMS). You will work on workflow automation, system validation, API integrations, and cloud-based infrastructure, ensuring compliance while optimizing quality operations.

1. Develop and maintain eQMS workflows, ensuring regulatory compliance.
2. Automate quality system procedures using Python, PowerShell, or Bash to reduce manual effort.
3. Integrate eQMS with enterprise tools (e.g., Jira, Azure DevOps, ERP, PLM) via RESTful APIs.
4. Build automated testing and validation for eQMS configurations to ensure compliance.
5. Implement GitHub Actions or Azure DevOps Pipelines for automation workflows.
6. Deploy real-time dashboards and reporting for compliance tracking and quality metrics.
7. Design practical notifications and alerts to reduce lead time and content switching.
8. Lead system validation efforts, ensuring CSV (Computer System Validation) compliance.
9. Maintain audit trails, data integrity, and access controls for regulatory compliance.
10. Support internal and external audits, ensuring seamless documentation and compliance.
11. 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.

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