| Location | Stockholm, Sweden |
|---|---|
| Business Sector | Medical Device |
| Contact name | Aimee Brenner |
| Contact email | |
| Job ref | 26623 |
| Published | 3 days ago |
Senior Quality Systems Engineer
Stockholm, Sweden or Europe | Full-time Remote or Hybrid
Our client develops innovative medical technologies that enhance healthcare outcomes. As a Senior Quality Systems Engineer, you will be the technical owner of their Quality Management System (QMS) infrastructure, ensuring it operates as a strategic enabler for the organization. You will focus on document control, change control, configuration management, and eQMS platform administration while driving continuous improvement through measurement, analysis, and optimization.
This role is critical to their success - you will build and maintain the systems foundation that enables every aspect of quality operations, design controls, and regulatory compliance. You will bring an engineering mindset to quality systems management, leveraging automation, data analytics, and digital tools to create a robust, user-friendly QMS infrastructure. By implementing systematic measurement and analysis of QMS performance, you will identify opportunities for optimization and drive meaningful improvements that enhance both compliance and business efficiency.
You will work at the intersection of quality, technology, and process excellence, ensuring the QMS scales effectively as the organization grows while maintaining the highest standards of compliance and operational effectiveness.
• Manage document control for QMS documents and records, ensuring proper lifecycle management in accordance with ISO 13485, FDA QSR, and EU MDR requirements.
• Oversee change control processes, ensuring all changes to QMS documentation, devices, and systems are properly evaluated, approved, implemented, and verified.
• Administer and optimize the eQMS platform (Azure DevOps), including repository management, access control, workflow configuration, and system integrations.
• Manage configuration management activities, ensuring version control, traceability, and configuration item identification across the QMS and product lifecycle.
• Develop and maintain document templates and standardized formats to ensure consistency across the QMS.
• Implement automated workflows for document approval and change control using Azure DevOps, Power Automate, and related tools.
• Establish and maintain QMS performance metrics, dashboards, and analytics to measure system effectiveness, identify trends, and support data-driven decision-making.
• Lead continuous improvement initiatives for QMS infrastructure through systematic analysis of performance data, user feedback, and process inefficiencies.
• Conduct regular assessments of QMS processes to identify optimization opportunities and implement improvements that enhance efficiency and compliance.
• Develop and deliver training on document control, change control, and eQMS system usage to ensure user competency.
• Act as technical expert and system owner for eQMS platform functionality, maintenance, validation, and continuous improvement.
• Support internal and external audits by ensuring documentation systems demonstrate compliance and control.
• Collaborate with cross-functional teams to ensure quality systems infrastructure supports their workflows and regulatory obligations.
• 5+ years of experience in document control, change control, or QMS administration within the medical device or pharmaceutical industry.
• BSc or MSc degree in engineering, computer science, quality management, or a related field, or equivalent professional experience.
• Strong working knowledge of ISO 13485, FDA QSR (21 CFR 820, Part 11), and EU MDR requirements for document and change control.
• Hands-on experience with eQMS platforms and digital quality systems, preferably Azure DevOps or similar version control systems.
• Proven experience implementing document control systems and change management processes in regulated environments.
• Engineering mindset with strong problem-solving skills and experience with automation and process optimization.
• Understanding of version control principles (Git) and branching/merging strategies for documentation management.
• Experience with workflow automation tools such as Power Automate or scripting languages (PowerShell, Python).
• Strong attention to detail and commitment to data integrity and compliance.
• Excellent organizational skills with the ability to manage multiple system improvements simultaneously.
• Excellent written and verbal communication skills in English.
• High level of self-motivation with the ability to operate independently and drive continuous improvement.
• Experience with computer system validation (CSV) for eQMS platforms.
• Knowledge of IEC 62304, ISO 14971, and design control requirements.
• Experience with API integrations, database management, and reporting/analytics for quality metrics.
• Background in software development, DevOps practices, or systems administration in regulated industries.
• Experience implementing AI-driven documentation tools and automated compliance checking.
• Knowledge of ISO 27001, GDPR, and information security principles for quality systems.
• Familiarity with other eQMS platforms (Veeva Vault, MasterControl, TrackWise, Greenlight Guru).
• Experience supporting Notified Body audits and FDA inspections focused on quality systems infrastructure.
• Swedish language skills.
At our client, the Senior Quality Systems Engineer will work in an innovative environment, building quality systems infrastructure that enables breakthrough medical technologies while ensuring regulatory compliance. They leverage modern engineering practices and automation to create a world-class QMS that supports both compliance and business agility.