Quality Engineer - MedTech (m/w/d) TZ/VZ
Core
Quality Assurance Engineer responsible for validation, qualification, calibration, and risk management in regulated MedTech manufacturing environments.
Role type
Quality Assurance Engineer (MedTech)
Builds
Validated equipment, test methods, software, and production systems for medical devices
Domain
MedTech / Life Sciences / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Equipment and software validation (GAMP 5), Risk Management (ISO 14971, PFMEA), Change Control management, Root Cause Analysis, CAPA management, Cleanroom monitoring, SAP QM/PM, Power BI, Six Sigma tools
Preferred skills
TrackWise, MasterControl, LIMS systems
Technologies
SAP, Power BI, Power Automate, MS Office 365
Responsibilities
Plan and execute validation of equipment, test methods, and software; Manage calibration programs and cleanroom monitoring; Lead change controls and audit preparations; Organize and review Process FMEAs
Seniority
Mid-level (3+ years experience)
