Medical Device Quality Fascilitator Europe: Senior-Experianced- available

Medical Device Quality Fascilitator Europe: Senior-Experianced-

Profileimage by Anonymous profile, Medical Device Quality Fascilitator Europe: Senior-Experianced-
  • CH-8001 Zürich Freelancer in
  • Graduation: Master-Level
  • Hourly-/Daily rates:
  • Languages: German (Native or Bilingual) | English (Full Professional) | French (Limited professional)
  • Last update: 15.05.2020
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CV - Hans Qualified

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One-pager Hans_Spichiger

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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-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
  • 01/2010 - 01/2019

  • Interim Manager, Consultant, Coach and Auditor for Business Excellence Services GmbH, Zürich & Geneve - Switzerland
  • international assignements in Projects for companies as e.g. Candela, Novartis, Roche, Zimmer, Medela, Getting

  • 01/2013 - 01/2014

  • Depuy-Synthes Subject Matter Expert (SME for CAPA-; Complaint-; Field Action Management at Head-Quarter)
  • CAPA process reengineering and sat in place trained new EtQ
    software tools. Coaching Project- and Product-Managers in working
    through their assigned individual CAPAs. Remediation of global
    legacy CAPAs. Supporting the complaint- as well the field action-
    (FSCA) Management by new software tools within related CAPAs.

  • 01/2012 - 01/2013

    • Sias AG
    • 50-250 employees
    • Pharmaceuticals and medical technology
  • QA/RA Manager
  • Diagnostics" (IVD) liquid handling robots' manufacturing. Lead a
    small team for electrical safety CE product approvals.
    QMS enhancement as well as Change-, and CAPA-Management.

  • 01/2011 - 01/2012

    • Medtronic-Invatec
    • 50-250 employees
    • Pharmaceuticals and medical technology
  • Site Quality Manager
  • Balloon- & Nitinol Stent-Catheter manufacturing. Quality
    Operations including Q-Engineering & -Control.
    Leading 15 direct and indirect reports.

  • 01/2009 - 01/2011

    • Medical Device Industry
    • < 10 employees
    • Pharmaceuticals and medical technology
  • Consultant of Business Excellence Services
  • Assessments and Audits intern as well as on suppliers' sites as a
    Consultant of Business Excellence Services.

  • 01/2007 - 01/2009

    • forteq Healthcare
    • 50-250 employees
    • Pharmaceuticals and medical technology
  • Head of Quality Management
  • ? Head of Quality in the manufacturing of combined medical
    devices for GlaxoSmithKline's asthma treatment program.
    ? Plastic injection, -printing and micro assembling in clean room.
    ? Clean room and manufacturing extension, including the
    Qualification and Validation management.
    ? Responsible for the Quality Assurance and - Control department
    including product release as well as for the Quality system on site.
    Leading 20 direct- and indirect-reports.
    ? Management system-, Document-, Compliance-, CAPA-, Change-
    and Complaint responsibility according to US- and EU-Regulations.

  • 01/2003 - 12/2005

    • 50-250 employees
    • Industry and mechanical engineering
  • Quality Manager including HSE
  • responsibilities for the internationally active medical devices and
    measurement systems Electronics Contract Manufacturer for PCB's.
    ? Entrusted with the company's management systems (certified against
    ISO 9001; 13485; 14001), and the BEX process management.

  • 01/2001 - 12/2002

    • Dr. Schnetzer Consulting
    • < 10 employees
    • Banks and financial services
  • Consultant
  • ? Consultant for methodical process design and -management in
    IT departments of important banks and insurance companies.
    ? Lecturer for Business management as part of after degree studies
    e.g. at Kaleidos-AKAD or IFA: "Master of Business Process Engin."

  • 01/1999 - 01/2001

    • Telekurs-Payserv, Zürich & Schweiter Technologies
    • 50-250 employees
    • Internet and Information Technology
  • Quality Manager
  • machinery company. Including management of the Goods in
    Department at the Headquarter and strategic outsourcing projects.
    ? Business Organizer for the largest computer center of the Swiss banks.

  • 01/1994 - 01/1999

    • ABB
    • 1000-5000 employees
  • ABB Customer Focus Manager: includes Business Excellence; QM; QA; Safety-; Environmental-; Security- and Training-Management
  • (Quality- and Environmental Management, Security, Safety, Training)
    ? Project management in the setting up of management systems.
    (ISO 9001; 14001, Health & Safety), in three languages at 14 sites.
    ? Certification of several systems, according to ISO standards as the
    leading Project Manager.
    ? Auditing and Assessments according to EFQM within the ABB Group
    ? Project Management Trainer for the 80 technical Project Manager's
    around Switzerland.
    ? Management of the training and education of 120 apprentices with 7
    assistants at 14 sites all over Switzerland.

  • 01/1990 - 01/1994

    • Hunkeler Entsorgungssysteme
    • 10-50 employees
    • Industry and mechanical engineering
  • Project Manager & Electrical Engineering
  • ? Build-up and management of a team executing the electrical
    engineering for the construction of bulk goods installations.
    ? CE-conform documentation of complex industrial plant installations
    and organization.
    ? Execution of extensive customer trainings e.g. in Italy and Geneva

    ? Validation/ Qualification of huge paper processing equipment in
    banks, the printing industry as well as private and public recyclers.
    ? Project management and roll out of Computer Aided Engineering
    (CAE) as well as PLC system application for the equipment control.

  • 01/1977 - 01/1986

    • CKW, Reiden/ Luzern and Weber & Cie AG
  • Electrical installations and industrial control technician
  • for power electronics including vocational baccalaureate.

International experianced: Europe, US, Asia, Africa
Preferred for working in western Europe
Experienced Swiss Medical Device Quality Leader and Expert, speaking English, French and German
·        Professional Experience: 40 years
·        Leadership Experience: 18 years
·        Quality Management Experience: 23 years
·        Supplier Quality Management Experience: 20 years
·        Medical Device Manufacturing Experience: 18 years
·        Own Swiss company: in the last 6 years
Let me know about your immediate needs as:
For instance, consulting, interim solutions or hands on work in:
Design Control for Product Development – Supplier/CMO Management
Management System adaption – Risk-Assessments/Management
Mergers and Acquisitions GAP-Analysis e.g. DHF/ STED/ Tech-File/ CAPA …
Compliance Management e.g. MDD/ MDR, 21 CFR 820 …