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Hans SPICHIGER

GENEVA

En résumé

Excellents services en matière d'assurance qualité
Faciliter le développement et fabrication des dispositifs médicaux
Leader et expert expérimenté dans le domaine qualité qui parle anglais, français et allemand à votre service :
• Développement de produits
• Supply Chain Management
• Risk management (ISO 14971)
• Systèmes de gestion (ISO 9001 – 13485 – MDR – 21 CFR 820)
• Mergers and Acquisitions
• Systèmes d'administration de médicaments/ Produits combinés médicaux/ pharmaceutiques

Mes compétences :
Audit
Drug Delivery
Orthopedic
CAPA
IQ OQ PQ
Process Reengineering
ISO 13485
Injection Moulding
Catheter
Stents
Electrical Engineering
Internal Audit
Management support
Mechanical Product Design
Medical Devices
Project Management
Quality Management Systems
Process design
Validation
ISO 9001
Design
Installation
Operational qualification
Qualification
MDR
GMP
CFR 820
CGMP
MDD
2017/745
QM
QA
Medical Devices Regulation
AQ

Entreprises

  • Business Excellence Services Zürich, Switzerland, - Intérim Manager & Experte Medical Devices; Project Manager; Senior Specialist/ SME; Auditor

    2012 - maintenant International active Manager, Consultant, Coach, Auditor and Free-lancer with own Company (ISO9001, ISO13485 & ISO14971 Risk-Management - MDR & CFR820 - MDSAP)
    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-Management – 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)

  • unspecified divers companies, Switzerland, - Head of Quality; Medical Devices Senior Manager/ Director

    2003 - 2012 Medical Device Business (ISO9001, ISO13485 & CFR820 – MDD): 2003 till 2012
    Electronics production like printed circuit boards (PCB) – Injection Moulding – Testing
    Sterilization – Drug delivery systems - Catheters – Balloons - Stents - combination Products
    IVD Liquid-Handlers/ Robots – Cleanrooms – Validation/ Qualification IQ/ OQ/ PQ – CE-marking

  • divers unspecified companies Luzern, Switzerland - Project Manager, Manufacturing Electrical Equipment; Project Manager Electrical Engineering

    1977 - 2003 Project Manager Manufacturing and Production & set-up of Electrical Equipment in Europe
    Project Manager Electrical Engineering – Project Management – QMS & Training – Leadership

Formations

  • Europe (Bern; Berlin;)

    Bern; Berlin; 1990 - 2020 divers

    EOQ TQM-Leader
    Diploma for proven knowledge,
    skills and expertise in general
    management by strategy based
    lean processes outputting to
    relevant stakeholders.
    People- & Project Management

    EOQ Quality-Auditor
    Diploma for proven knowledge,
    skills and expertise in auditing
    Management Systems,
    Processes and Products
    following EN/ ISO 19011:2011.

    EOQ Quality System Manager
    Diploma for proven knowledge

Réseau

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