Sachbearbeiter:in Qualitätsmanagement (m/w/d) – Medical Devices
Core
Quality Management specialist supporting ISO 13485 compliance, operational processes, and cross-functional projects in a MedTech 3PL and importer.
Role type
Quality Management Associate (MedTech)
Builds
Quality Management System (QMS) documentation, SOPs, and operational process improvements for medical device clients
Domain
Medical Devices / MedTech / Logistics
Deliverable
dashboards & analysis
Required skills
ISO 13485 knowledge, process analysis, regulatory documentation, project coordination, risk-based controls
Preferred skills
MedTech/Pharma/Healthcare experience, validation experience, software solution development
Technologies
MS Office, digital documentation systems
Responsibilities
Maintain and develop ISO 13485 QMS; Create and update SOPs and quality records; Support quality deviations and customer complaints; Coordinate cross-functional projects between Quality and Operations; Analyze processes for optimization potential; Conduct risk-based controls and sampling
Seniority
Junior to Mid-level, hands-on IC
