Medical Devices

Xenios AG / Fresenius Medical Care

External engineering cooperation partner for launch system ECMO
• Quality management according to ISO
13485 and FDA regulatory
• qualification and validation of production equipment and processes
• Preparation and operation of audits
• Places of operation: Heilbronn, Stolberg, Radeberg, Reutlingen

Roche Diagnostic

Supplier Quality Assurance Manager,
Process engineering insulin pumpe Solo M
• supplier quality
• process development
• Quality issues Assembly line
Validation of the line, OQ, PQ and RED
• FDA, Medicine Devices, ISO 13485
• Process audits of plastic injection moulding,
Packaging, sterilization
• Places of operation: Mannheim, Joensuu – Finland