Quality Management Engineer (m/f/d) QMS and Compliance

In this role you will strengthen Getinge’s quality management system to ensure life-saving devices meet regulatory and customer expectations. You will own the internal audit program, drive CAPA coordination, and support QA initiatives across the Critical Care product area. You will collaborate with cross-functional teams to improve processes, prepare for audits, and report KPIs that reflect quality performance. This is an impact-driven, hands-on position at a global medical technology company with a strong focus on continuous improvement.

• competitive compensation and benefits package
• wellness allowances
• generous family benefits
• joint company activities
• support for well-being and goals

• Own the internal audit process including planning and follow-up of findings
• Conduct internal audits as auditor
• Support external audits by notified bodies, authorities, and customers
• Coordinate CAPA projects and support Quality-related initiatives
• Collaborate on internal Quality projects (Management System Plan, CAPA)
• Contribute to process improvements and alignment across sites
• Provide and report monthly QMS KPIs
• Maintain, review, and approve QMS documentation and records as QA specialist

• Degree in medical technology, engineering, science, or a similar relevant field
• Minimum 3 years of hands-on Quality and Environmental Management experience, ideally ISO 13485 environment
• Knowledge of applicable standards/regulations (ISO 13485, FDA, EU MDR)
• Training in QM / ISO 13485 / FDA / EU MDR (external/internal)
• Ideal: Internal Auditor training
• Experience in quality- and environmental-related projects (CAPAs, EU MDR uplift) is a plus
• Fluent in English (written and spoken); Swedish or German is an advantage
• On-site presence 1–2 days/week and willingness to travel

• Result-oriented
• Collaborative team player
• Ownership of work with ability to work independently
• Quality Management System (QMS)
• Internal auditing and CAPA coordination
• Regulatory knowledge: ISO 13485, FDA, EU MDR