Quality Engineer (QMS, CAPA, Training)

About the role

Siemens Healthineers is looking for a highly organized and detail-oriented Quality Engineer to support the operation of its Quality Management System (QMS). The role covers controlled documentation, training processes and Corrective and Preventive Actions (CAPAs), and helps ensure compliance with regulatory requirements, inspection readiness and quality system effectiveness.

Key responsibilities

• Manage and maintain controlled quality documents and records according to internal procedures and regulatory requirements.
• Coordinate document creation, review, approval, revision and archival in the electronic document management system, and keep controlled documents updated.
• Support users with document management processes and system questions, and ensure quality records are complete, accurate, traceable and audit-ready.
• Coordinate quality training programs, support the development of training curricula and learning plans, and partner with process owners so training meets regulatory and procedural expectations.
• Promote awareness of quality system requirements and compliance obligations.
• Support CAPA management, including action tracking, follow-up and due-date monitoring, and assist with quality investigations by collecting evidence.
• Prepare quality metrics and reports on investigations, CAPAs and overall quality system performance.

Required profile

• Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration or a related field.
• Experience in quality systems, document control, training management, CAPAs or a related quality function.
• Knowledge of regulatory standards such as ISO 13485, MDR and MDSAP.
• Experience in a regulated environment, preferably healthcare, medical devices or a similar industry.
• Strong process- and compliance-oriented mindset, attention to detail, organization and follow-through, and ability to handle multiple priorities.