About the RoleLocation: Stockholm, Sweden or Europe | Full-time Remote or HybridAt Neko Health, we are developing innovative medical technologies that enhance healthcare outcomes. 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.ResponsibilitiesDevelop 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.Requirements5+ 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 HaveExperience 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'll shape 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!About the Engineering TeamDistributed and Remote FirstWe are nearly 100 full time engineers at the company, working from Berlin, Chamonix, Hamburg, Lisbon, Marseille, Vilnius, and Stockholm, spanning diverse disciplines such as Hardware Engineering, Firmware Development, Electrical Design, Algorithm Development, Machine Learning Development, Optronics Research, Frontend Development and more. We don't expect people to join us with a specific tech knowledge, but we do expect you to work with our tools. We use a mix of React, Typescript, C++, and Python. Our APIs are written in C# with ASP.NET Core, uses Azure Cosmos DB, and Azure Active Directory for authentication.Our headquarters and our hardware development team are in Stockholm, Sweden.We are a Remote First company; however, it is of course much easier to work remotely as a software engineer than a hardware or firmware engineer (since they require access to hardware or devices occasionally). Software engineers based in Stockholm work maybe one day a week or one day every two weeks from the office.We meet a couple of times per year to get to know each other and have fun.Organization and Way of WorkingThe engineering team is divided into smaller cross functional project teams that each focus on a specific goal or target, where some groups are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We strive to create groups which are cross-functional and able to complete their goals without dependence on other teams, even though this is of course not always possible.Groups track goals on a yearly and quarterly basis with goal follow-up across the entire engineering organization on a bi-weekly basis. Most groups do internal planning on a bi-weekly basis, but in the end it's up to the group to decide how they want to work.We have, however, mandated that all groups must present their progress or failures or hacks at our bi-weekly engineering demo, a fun meeting/presentation where we talk about everything from short-circuiting power-modules, how hard it is to calibrate cameras or align polygons in space, to neat new command line tools for operations, a new auth mechanism in the backend, a cool new way to visualize health data or a new feature which helps our doctors be more productive.We have a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else.AI DisclaimerWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
