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Last update: 15.05.2020

Medical Device Quality Fascilitator Europe: Senior-Experianced-

Graduation: Master-Level
Hourly-/Daily rates: show
negotiable depending role and geography
Languages: German (Native or Bilingual) | English (Full Professional) | French (Limited professional)

Keywords

Document Management PCB Manager Consultant passivation coating Coach Auditor ortho implant device machine delivery drug systems Assembly Management Electronics Packaging sterilization Clean room Validation Qualification quality ISO 14971 iso 13485 ISO 9001 iso 19011 MDR 21 CFR 820 CAPA PRRC Q-Rep Supplier Quality Manager Injection molding Injection moulding Supplier management design control Evaluation Transfer Electronic Engineering ELECTRICAL

Attachments

Hans_200225.pdf
Hans_Spichiger_facts_1-6.pdf

Skills

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

Project history

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
QA/RA Manager
Sias AG (50-250 employees)
Pharmaceuticals and medical technology
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
Site Quality Manager
Medtronic-Invatec (50-250 employees)
Pharmaceuticals and medical technology
Balloon- & Nitinol Stent-Catheter manufacturing. Quality
Operations including Q-Engineering & -Control.
Leading 15 direct and indirect reports.

01/2009 - 01/2011
Consultant of Business Excellence Services
Medical Device Industry (< 10 employees)
Pharmaceuticals and medical technology
Assessments and Audits intern as well as on suppliers' sites as a
Consultant of Business Excellence Services.

01/2007 - 01/2009
Head of Quality Management
forteq Healthcare (50-250 employees)
Pharmaceuticals and medical technology
? 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
Quality Manager including HSE
ESCATEC (50-250 employees)
Industry and mechanical engineering
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
Consultant
Dr. Schnetzer Consulting (< 10 employees)
Banks and financial services
? 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
Quality Manager
Telekurs-Payserv, Zürich & Schweiter Technologies (50-250 employees)
Internet and Information Technology
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 Customer Focus Manager: includes Business Excellence; QM; QA; Safety-; Environmental-; Security- and Training-Management
ABB (1000-5000 employees)
(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
Project Manager & Electrical Engineering
Hunkeler Entsorgungssysteme (10-50 employees)
Industry and mechanical 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
Electrical installations and industrial control technician
CKW, Reiden/ Luzern and Weber & Cie AG
for power electronics including vocational baccalaureate.

Time and spatial flexibility

International experianced: Europe, US, Asia, Africa
Preferred for working in western Europe

Other

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 …

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