Quality Management Engineer (m/f/d) QMS and Compliance
Core
Own the internal audit process, coordinate CAPA projects, and support external audits to ensure compliance with quality standards for life-saving medical devices.
Role type
Quality Management Engineer (QMS and Compliance)
Builds
Internal audit schedules, CAPA projects, and QMS documentation aligned with ISO 13485 and EU MDR.
Domain
Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Internal auditing, CAPA coordination, QMS documentation management, ISO 13485 knowledge, EU MDR knowledge, FDA regulations knowledge, KPI reporting, process improvement
Preferred skills
External audit support, Quality project leadership, stakeholder collaboration
Technologies
ISO 13485, EU MDR, FDA regulations
Responsibilities
Plan and execute internal audits, coordinate Corrective and Preventive Action (CAPA) projects, support external audits by notified bodies and authorities, maintain and approve QMS documentation, report monthly KPIs, drive continuous process improvement.
Seniority
Mid-level, hands-on IC