Profilbild von Hans Spichiger Medical Device Quality Fascilitator Europe: Senior-Experienced aus Zuerich

Hans Spichiger

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Letztes Update: 25.04.2023

Medical Device Quality Fascilitator Europe: Senior-Experienced

Firma: Business Excellence Services
Abschluss: Master-Level
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (gut)

Dateianlagen

Hans-E-221115_240123.pdf
Hans-D-221128_240123.pdf
Hansen-s-Latest-Projects-overview-22_240123.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

Projekthistorie

01/2010 - bis jetzt
international assignements in Projects for companies as e.g. Candela, Novartis, Roche, Zimmer, Medela, Getting, Candela, Ritter, Agilent, Nespresso
(Industrie und Maschinenbau)


07/2022 - 12/2022
Interim Validation Management Robotnics
(Industrie und Maschinenbau)

Interim Validation Management: Prozess Risk Assessment komplexer elektrischer  (IEC60601-1) / mechatronischen Robotern für deren MDR-Zulassungl.

06/2021 - 06/2022
Interim Head of QM für Aluminum-Folien
(Industrie und Maschinenbau)

Interim Head of QM für Aluminum-Folien Tiefziehprozesse & -Verbesserung. Mitarbeiter-Coaching sowie internationales Lieferanten- und Reklamations-Management.

01/2021 - 12/2021
Zertifizierungs- und Validierungs- GMP Comissioning-Strategie für die technische Infrastruktur
(Industrie und Maschinenbau)

Cytiva Cell Therapy Signy Neubau-Projekt QA/RA-Manager. Beauftragt mit der Entwicklung & Implementierung einer Zertifizierungs- und Validierungs- GMP Comissioning-Strategie für die technische Infrastruktur wie z.B. Reinräume.

01/2020 - 12/2020
Interim QA-Verantwortlicher: Manufacturing Transfer nach Mexiko & Notified Body evaluation
(Industrie und Maschinenbau)

Interim QA-Verantwortlicher in Dänemark, für Software release, Manufacturing & Distribution von Class IIb Laser equipment für Candela.

Projekt: Manufacturing Transfer nach Mexiko & Notified Body evaluation.

01/2018 - 12/2020
Quality Expert Drehen, Fräsen, Reinigen, Oberflächenbehandlung und Steril Verpackung
(Industrie und Maschinenbau)

Experte im Q-Management und Q-Engineering für die Produktion von orthopädischen- /arthroplastischen Implantaten und -Werkzeugen. Drehen, Fräsen, Reinigen, Oberflächenbehandlung und Steril Verpackung.


07/2017 - 12/2017
Re-Engineering Produkt Entwicklungs-Prozesse, cGMP 21CFR820.30/ ISO 13485:2016 und MDR Design Control
(Industrie und Maschinenbau)

Re-Engineering des Medela Produkt Entwicklungs Prozesses, bezüglich cGMP 21CFR820.30/ ISO 13485:2016 und MDR Design Control Anforderungen: Soft-, Hardware und mechanisches Design von Class IIb Pumpen.

11/2016 - 06/2017
Interim sen. Manager ISO 14971 Risk- & Change-Management
(Industrie und Maschinenbau)

Interim sen. QE-Experte im Quality Assurance des Maquet daily business, zur Herstellung seiner Oxigenatoren z.B.  ISO 14971 Risk- & Change-Management.

03/2016 - 11/2016
CAPA remediation & compliance Projekt, IVD
(Industrie und Maschinenbau)

Experte im Roche CAPA remediation & compliance Projekt, für IVD Blut Analyseautomaten und Blutgas-Sensoren Entwicklung / Produktion (IVD).

01/2015 - 09/2015
parenterales «drug delivery» System, Entwicklungs-Evaluation Kunststoff-Spritzguss Experte
(Industrie und Maschinenbau)

Norvartis Support für das Assessments, betreffend Produzierbarkeit eines neuartigen parenterales «drug delivery» System, in der Entwicklungs-evaluation. Assessment von Kunststoff-Spritzguss- und hochvolumen Montage-Werken in Europa und den USA.

06/2014 - 11/2014
Supplier Validation Expert Metallbearbeitungsprozesse, für orthopädische Implantate und deren Validierung
(Industrie und Maschinenbau)

Assessment/ Auditierung vieler Metallbearbeitungsprozesse, für orthopädische Implantate und deren Validierung (IQ/OQ/PQ), zur Gewährleistung von US-FDA-Auditbereitschaft, bei Zimmer Lieferanten (CMO) in Europa.

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 IVD
Sias AG (Pharma und Medizintechnik, 50-250 Mitarbeiter)

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 Katheter & Stents coated
Medtronic-Invatec (Pharma und Medizintechnik, 50-250 Mitarbeiter)

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 (Pharma und Medizintechnik, < 10 Mitarbeiter)

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 Inhaler production
forteq Healthcare (Pharma und Medizintechnik, 50-250 Mitarbeiter)

? 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 electronics PCB
ESCATEC (Industrie und Maschinenbau, 50-250 Mitarbeiter)

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 (Banken und Finanzdienstleistungen, < 10 Mitarbeiter)

? 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 (Internet und Informationstechnologie, 50-250 Mitarbeiter)

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 - 12/1999
Project Manager & Electrical Engineering
Hunkeler Entsorgungssysteme (Industrie und Maschinenbau, 10-50 Mitarbeiter)

? 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.

01/1994 - 01/1999
ABB Customer Focus Manager: includes Business Excellence; QM; QA; Safety-; Environmental-; Security- and Training-Management
ABB (1000-5000 Mitarbeiter)

(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.

01/1977 - 01/1986
Electrical installations and industrial control technician
CKW, Reiden/ Luzern and Weber & Cie AG

for power electronics including vocational baccalaureate.

Reisebereitschaft

Weltweit verfügbar
International experianced: Europe, US, Asia, Africa (Marocco)
Preferred for working in Europe

Sonstige Angaben

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 …
Profilbild von Hans Spichiger Medical Device Quality Fascilitator Europe: Senior-Experienced aus Zuerich Medical Device Quality Fascilitator Europe: Senior-Experienced
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