epias GmbH

DevOps Engineer

• Build, operate and continuously improve automated deployments and CI/CD pipelines
• Administer and optimize containerized applications using Docker and Kubernetes
• Automate infrastructure with Infrastructure as Code (e.g., Ansible or Puppet)
• Monitor, log and optimize performance of production systems
• Analyze and resolve complex incidents in Linux, Windows and network environments
• Work closely with development teams to improve monitoring and alerting strategies, as well as release and operational processes
• Maintain technical documentation and continuously improve the platform

Compliance

• Responsibility for the further development of our quality management system according to DIN EN ISO 13485
• Introduction and support of certification to DIN EN ISO 27001
• Planning, monitoring, control and improvement of the quality management system across all departments
• Support in maintaining and updating the technical documentation of our medical device
• Development of intelligent workflows for creating, maintaining and reviewing regulatory documentation
• Building an AI-supported management system with Jira and GitHub as central versioning and process platforms
• Integration of AI into quality, risk and documentation processes
• Preparation and execution of internal audits, including tracking of corrective actions
• Conducting quality management training for employees
• Monitoring and implementation of regulatory requirements in collaboration with our Responsible Person
• Preparation and support for the annual MDR surveillance audits and recertifications by the notified body
• Maintaining and further developing our documentation system in consultation with management
• Regular preparation of the Periodic Safety Update Report (PSUR), the clinical evaluation, and the Post-Market Clinical Follow-Up (PMCF) report, including monitoring of required data, and preparing and supporting management for the annual management review

DevOps Engineer

Head of Quality Management, Regulatory Affairs