04.09.2026 aktualisiert

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Medical Device (but not only) Quality Fascilitator Europe: Senior-Experienced

Zürich, Schweiz
Weltweit
Master-Level
Zürich, Schweiz
Weltweit
Master-Level

Profilanlagen

CV_Hans_Spichiger_one-page_260731.pdf

Über mich

I am your agile, hands-on partner for industrial process management under strict quality requirements, including in production. As an expert in ISO 9001 and ISO 13485 with over 30 years of project experience, you’ll benefit from my extensive practical knowledge on site.

Skills

ElektrotechnikEndoprothetikAuditsISO 9000ReinraumKorrektur- und VorbeugemaßnahmeLeiterplatteElektronikfertigungElektronikSterilisationSpritzgießenIso 13485Laser-ProjektmanagementQualitätsmanagementRisikoanalysePolierenIq/oq/pqTestenIntegrierte SystemeVerpackung und KennzeichnungSensorikOrthopädieKatheterisierungMdsapBeschichtung
Manager, Consultant, Coach, Auditor and Freelancer 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

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2015

Sprachen

DeutschMutterspracheEnglischverhandlungssicherFranzösischverhandlungssicher

Projekthistorie

international assignements in Projects for well known companies.

Industrie und Maschinenbau

Project Manager

SMELL Discettes GmbH

Pharma und Medizintechnik

< 10 Mitarbeiter

Re-Engineering of a Medical Device Product: Packaging, Plastic Injection Molding, Supply-Chain Management. Requirements Engineering, Software, Technical Documentation, Regulatory Affaires. QMS-Design and set-up.

Project trouble shooter & customer care, in the European aerospace industry, within the field of precision optics systems manufacturing

SwissOptic

Industrie und Maschinenbau

50-250 Mitarbeiter

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)

Interim Risk- & Validation Management in medical Robotnics

Hocoma

Industrie und Maschinenbau

50-250 Mitarbeiter

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

Interim Head of QM for Aluminum-Foil deep-drawing

Alupak

Industrie und Maschinenbau

50-250 Mitarbeiter

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

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.

Interim QA-Verantwortlicher: Manufacturing Transfer nach Mexiko & Notified Body evaluation

Ellipse-Candela

Industrie und Maschinenbau

10-50 Mitarbeiter

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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."

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.

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.

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.

Electrical installations and industrial control technician

CKW, Reiden/ Luzern and Weber & Cie AG
for power electronics including vocational baccalaureate.

Kontaktanfrage

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