02.10.2025 aktualisiert
Premiumkunde
100 % verfügbarMedical Device (but not only) Quality Fascilitator Europe: Senior-Experienced
Zürich, Schweiz
Weltweit
Master-LevelSkills
ManagementISO 14971iso 13485ISO 9001MDR21 CFR 820lieferantenmanagementProjekt ManagementMedizintechnikRisikomanagement
Manager, Consultant, Coach, Auditor and Free-lancer with own Company
(ISO9001, ISO13485 & ISO14971 Risk-Management - MDR & CFR820 - MDSAP)
Robotnics, Orthopaedic- & Arthroplasty Implants – Extracorporeal Circulation Devices (Heart-Lunge-Machines)
Drug Delivery Systems - IVD Sensors - Electronics
Assembling – Packaging in Cleanroom – Sterilization - Validation (IQ/OQ/PQ)
Metal Machining Processes & -Refinement as polishing, passivation, coating, cleaning
CAPA-Mgm. – Design & Development of Soft- and Hardware in integrated Systems
Design-Controls - External- & Internal Audits – Supplier-Management &
Evaluation – Laser Technology QA/RA-Lead (PRRC/ Q-Rep/ QB)
Electronics production – Injection Moulding – Testing – Sterilization
PCB – Drug delivery systems - Catheters – Balloons - Stents
IVD Liquid-Handlers – Cleanroom – IQ/OQ/PQ – CE-marking
Electrical Engineering – Project Management – QMS – Leadership
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischgut
Projekthistorie
Project trouble shooter & customer care, in the European aerospace industry, within the field of precision optics systems manufacturing.
Project Risk- & Validation-Management (e.g. FMEA & GAMP5)
Project Risk- & Validation-Management (e.g. FMEA & GAMP5)
Interim Validation Management: Prozess Risk Assessment komplexer elektrischer (IEC60601-1) / mechatronischen Robotern für deren MDR-Zulassungl.