freelance

Project Management: Redesign of instruments for eye surgery
Device Qualification
Process Qualification
Operator training
Documentation
- MFP, DHR, PMVP, …
- Work instructions, QC-planning …
- Supplier Management / Scope-change
Validation of documents and Processes
DQ, IQ, OQ, PQ, Risk analysis

Consultant to the Executive Board, COO and the QM in the area of Production, Lean Management, Continuous Improvement over all Branches.
Implementing Production processes based on Lean Management Methods
Change Management Methods
Continuous Improvement
IQ, OQ, PQ, PVT, Training
Spec. Requirements, FAT, SIT/SAT, Commissioning
Supplier Management / Qualification
Qualification of parts for Medical devices
- Plastics (CNC-machined parts /injection molding under cleanroom conditions)
- Aluminum
- Stainless steel
- Titan

Planning and transfer of a Manufacturing factory for Medical Devices from USA to Germany
Project Leader EMEA, Project Management. Documentation, validation new processes. CE-Qualification of equipment
Interim Value Stream Manager, Supplier Qualification, ISO 13485: 2016, FDA
PVT-Builds
Supplier Management / Qualification
Customer-specific qualification (SCR - Karl Storz China, DePuy Synthes Cork)

Planning and transfer of a CNC-Manufacturing Department for Medical Device Parts from Germany to UK (Poole) and China (Suzhou)
Project Leader Germany, Project Management. Documentation, validation new processes. SCR/SICR, IQ, OQ, PQ, PPAP/LAIR/FAIR including process capability study
First article sampling according to PPAP (Stryker)
Qualification/Validation on behalf of ISO13485
(DePuy Syntes)
Spec. Requirements, FAT, SIT/SAT, Commissioning
Supply Chain reorganization
Supplier Management / Qualification, ASL (Approved Supplier List)
Parts range:
- Plastic (CNC turned and milled parts)
- Aluminum
- Brass
- Stainless steel

Restart of an Automation Project Supplier qualification VDA 6.3 Project management Requirements - Specification sheets
FAT, SIT/SAT, Commissioning Machine qualification VDA 6.3 and IATF 16949 Process qualification ISO 13485
Supplier Management / Qualification
Implementation PMO in the Process Engineering Area Parts/Material range:
- Titanium
- Platinum
- Platinum/Iridium
- Gold

Order and Supply chain optimization between a German Company and an Italian Supplier Network (Lombardia/Venezia)
Project management Supplier management
Reorganization Logistics Planning and Processes and Availability of parts
Parts range:
- Aluminum Die casting