Hans Spichiger
Interim Manager, Consultant, Facilitator and Free Auditor
Erfahrungen
Jan. 2009 - Bis heute
15 Jahren 4 Monaten Zürich, Schweiz
Interim Manager, Consultant, Facilitator and Free Auditor
Business Excellence Services GmbH
- Project Management with focus on trouble shooting & customer care, product development/reengineering, regulatory management
- Supply-chain, risk and quality management, people management
- Experienced within Medical Device, Aerospace, Packaging, small & large equipment, optical & electrical-systems, metal & plastics
- Working for various accredited organizations as a freelance auditor for ISO 13485 and ISO 9001 systems since 2016
Projects:
- Medical Device product development, supply-chain and regulatory set-up for medical device re-engineering/launch and manufacturing (2024)
- Project trouble shooter & customer care in European aerospace industry, precision optics systems manufacturing, project risk & validation management including software validation (2023-2024)
- Validation management, design & process risk assessment of complex electrical mechatronics robots for MDR-approval (2022)
- Interim Head of QM in Aluminum-foil deep drawing process improvement, Nespresso supplier quality management (2021-2022)
- Cytiva Cell Therapy greenfield project - design & implementation support of certification, validation, GMP-commissioning strategy (2021-2022)
- Interim QA-Leader at Candela Denmark - software release, manufacturing and distribution of Class IIb Laser equipment (2020-2021)
- Quality support and interim quality management for IVD test equipment and dialysis supplies manufacturer (2020)
- Expert/SME in Q-Management for orthopedic and arthroplasty device production (2018-2020)
- Re-engineering of Medela Product Development Process for Class IIb pumps (2017)
- MDSAP preparation and coaching (2017)
- Interim QE-Expert for Maquet extracorporeal circulation devices (2017)
- Expert in Roche CAPA remediation for IVD blood analyzers (2016)
- Orthopedic implants DHF review for 21 CFR 820.30 compliance (2016-2017)
- Design control for Novartis parenteral drug delivery system (2015)
- Auditing orthopedic device manufacturers for Zimmer (2014)
- Depuy-Synthes SME - CAPA process reengineering (2013-2014)
- QA/RA Manager at Sias AG for IVD robots (2012-2013)
- Medtronic Site Quality Manager for medical devices (2011-2012)
- Quality initiatives support and auditing (2009-2010)
Jan. 2007 - Dez. 2009
3 Jahren Nidau, Schweiz
Head of Quality Management
forteq Healthcare
- Head of Quality in manufacturing of combined medical devices for GlaxoSmithKline's asthma treatment program
- Plastic injection, printing and micro assembling in clean room
- Clean room extension, including qualification and validation management
- Responsible for Quality Assurance and Control department, including product release and 20 direct/indirect reports
- Management system, document, compliance, CAPA, change and complaint responsibility according to US and EU Medical Device & GMP Regulations
Jan. 2003 - Dez. 2005
3 Jahren Au, Schweiz
Quality Manager
ESCATEC
Quality Manager including HSE responsibilities for internationally active medical devices and measurement systems Electronics Contract PCB-Manufacturer (ISO 9001, 13485, 14001)
Jan. 2001 - Dez. 2003
2 Jahren Küsnacht, Schweiz
Consultant and Lecturer
Dr. Schnetzer Consulting
- Consultant for methodical process design and management in IT departments of leading Swiss banks and insurance companies
- Lecturer for Business management as part of after degree studies at Kaleidos-AKAD and IFA: Master of Business Process Engineering
Jan. 1998 - Dez. 2002
3 Jahren Horgen, Schweiz
Quality Manager and Business Organizer
Telekurs-Payserv & Schweiter Technologies
- Quality Manager in international logistics network of machinery manufacturer, people management and strategic outsourcing projects
- Business Organizer in major Swiss banks computer center
Jan. 1993 - Dez. 1999
6 Jahren Zürich, Schweiz
Customer Focus Manager
ABB
- Project management for setting up management systems (ISO 9001, 14001, Health & Safety) in three languages at 14 sites
- Leading project manager for ISO certification
- Auditing and assessments according to EFQM within ABB Group
- Project Management Trainer for 80 Project Managers
- Managing training and development of 120 apprentices across 14 locations with 7 assistants
Jan. 1986 - Dez. 1994
9 Jahren Wikon, Schweiz
Project Manager
Hunkeler Entsorgungssysteme
- Built and managed electrical engineering team for bulk goods installations
- CE documentation of complex shredding systems in waste incineration plants
- Customer training delivery in Italy and Geneva
- Validation/qualification of paper processing equipment for banks, printing industry and recyclers
- Project management of CAE and PLC system implementation for equipment control
Jan. 1976 - Dez. 1987
10 Jahren Aarburg, Schweiz
Apprentice
CKW and Weber & Cie AG
Apprenticeship in electrical installations and industrial control technician for power electronics including vocational baccalaureate
Zusammenfassung
Gerne unterstütze ich ihren Kunden, international und mit den Sprachen
Deutsch,
Englisch oder
Französisch;
Nach seinem Bedarf an Tagen und Dauer.
• 40 Jahre Berufserfahrung - 20 davon in der Medizintechnik.
• 25 Jahre Projekt-, Quality-, Supply-Chain-, Risk-, Validation-Management:
ISO 9001 & ISO 13485.
Sprachen
Deutsch
Muttersprache
Englisch
Verhandlungssicher
Französisch
Verhandlungssicher
Ausbildung
Okt. 1977 - Juni 1986
CKW
Electrical installations and industrial control technician for power electronics · Reiden, Schweiz
Zertifikate & Bescheinigungen
CPMS Certified Professional for Medical Software
EOQ Business Excellence Assessor
EOQ Environmental System Manager
EOQ Quality System Manager
EOQ Quality-Auditor
EOQ TQM-Leader
Medical Mountains Validation Manager
PTS Expert of GMP
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