Hans Spichiger
interim Manager & Medical Device Expert
Experience
Jan 2024 - Dec 2024
1 yearMedical Device Product Development Consultant
Hans Spichiger Business Excellence Services GmbH
- Medical Device product development, supply-chain and regulatory set-up, with regard to a medical device re-engineering/ launch and manufacturing.
Jan 2023 - Dec 2024
2 yearsProject Troubleshooter and Customer Care Consultant
Hans Spichiger Business Excellence Services GmbH
- Project trouble shooter & customer care, in the European aerospace industry, within the field of precision optics systems manufacturing.
- Project Risk- & Validation-Management including Software-Validation.
Jan 2022 - Dec 2022
1 yearInterim Head of QM
Hans Spichiger Business Excellence Services GmbH
- Interim Head of QM in Aluminum-foil deep drawing process improvement.
- People- and international Nespresso Supplier Quality Management.
Jan 2022 - Dec 2022
1 yearValidation Management Consultant
Hans Spichiger Business Excellence Services GmbH
- Validation (FMEA, IQ OQ; PQ) Management, assigned with the Design- & Process Risk Assessment of complex electrical (IEC60601-1) mechatronics robots for MDR-approval following ISO 14971.
Jan 2021 - Dec 2022
2 yearsConsultant for Design & Implementation Support (Cytiva Cell Therapy Project)
Hans Spichiger Business Excellence Services GmbH
- Cytiva Cell Therapy greenfield project; assigned with Design- & Implementation-Support of a Certification-, Validation-, GMP-Commissioning-Strategy, for the technical Infrastructure, e.g., clean rooms.
Jan 2020 - Dec 2021
2 yearsDenmark
Interim QA Leader
Hans Spichiger Business Excellence Services GmbH
- Interim QA-Leader in Denmark, assigned with the Software release, Manufacturing and Distribution of Class IIb Laser equipment for Candela, including international Notified Body- & Manufacturing- Transfer Project.
Jan 2020 - Dec 2020
1 yearGermany
Quality Support and Interim Quality Management Consultant
Hans Spichiger Business Excellence Services GmbH
- Quality Support and Interim Quality Management for a manufacturer in the IVD test equipment supply chain and e.g. dialysis supplies in Bavaria.
Jan 2018 - Dec 2020
3 yearsExpert/SME in Q-Management and Q-Engineering
Hans Spichiger Business Excellence Services GmbH
- Expert/SME in the Q-Management/ Q-Engineering for Orthopedic- and Arthroplasty Device- and tool-production: Turning, milling, cleaning, surface treatment and sterile packaging.
Jan 2017 - Dec 2017
1 yearConsultant for MDSAP Preparation Support and Mock-Audit Coaching
Hans Spichiger Business Excellence Services GmbH
- MDSAP Preparation Support and Mock-Audit Coaching.
Jan 2017 - Dec 2017
1 yearConsultant for Product Development Process Re-Engineering (Medela)
Hans Spichiger Business Excellence Services GmbH
- Re-Engineering of the Medela Product Development Process, regarding cGMP 21CFR820.30/ ISO 13485:2016 and MDR Design Control requirements, for Soft- & Hardware-Design regarding Class IIb pumps.
Jan 2016 - Present
9 years 7 monthsZürich, Switzerland
Free Auditor
Hans Spichiger Business Excellence Services GmbH
- Working for various accredited organizations as a freelance auditor, regarding systems according to ISO 13485 and ISO 9001.
Jan 2016 - Dec 2017
2 yearsConsultant for DHF Review (Orthopedic Implants)
Hans Spichiger Business Excellence Services GmbH
- Orthopedic- and arthroplasties Implants Design History File (DHF) review regarding compliance to 21 CFR 820.30 Design Control requirements.
Jan 2016 - Dec 2016
1 yearInterim Senior QE Expert / Risk & Change-Management Expert
Hans Spichiger Business Excellence Services GmbH
- Interim Sen. QE-Expert for Maquet Extracorporeal Circulation Devices (e.g. Oxygenator) manufacturing as e.g., ISO 14971 Risk- & Change-Management Expert in a Roche CAPA remediation & compliance Project, of IVD Blood Analyzers/gas sensor production (IVD).
Jan 2015 - Dec 2015
1 yearDesign Control Consultant (Novartis Project)
Hans Spichiger Business Excellence Services GmbH
- Assigned by Novartis with Design Control for a new parenteral drug delivery system.
- Manufacturability Assessments during the design evaluation.
- Assessing of potential plastic injection molding and/ or high-volume assembly contractors in Europe and the US.
Jan 2014 - Dec 2014
1 yearAuditor and Process Validation Consultant (Zimmer Project)
Hans Spichiger Business Excellence Services GmbH
- Assessing/ auditing (orthopedic- and arthroplasties device) metallurgy process validation (IQ/OQ/PQ) of multiple potential new as well as existing Zimmer contract manufacturers around Europe for FDA audit redness.
Jan 2013 - Dec 2014
2 yearsSubject Matter Expert (Depuy-Synthes Project)
Hans Spichiger Business Excellence Services GmbH
- Depuy-Synthes Subject Matter Expert (SME).
- CAPA- 8D-Process reengineering and setting in place/ trained new EtQ software tools.
- Coaching of 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.
Jan 2012 - Dec 2013
2 yearsQA/RA Manager
Sias AG
- Engagement at Sias AG, as QA/RA Manager for “in Vitro Diagnostics” (IVD) liquid handling robots’ manufacturing.
- Lead a small team for electrical safety CE/ CB-Scheme product approvals.
- QMS, Change-, and CAPA-Management.
Jan 2011 - Dec 2012
2 yearsSite Quality Manager
Medtronic
- Engagement as Medtronic Site Quality Manager for Drug Eluting Balloon- & Nitinol Stent-Catheter manufacturing.
- Quality Operations including Q-Engineering & -Control.
- Leading 15 direct and indirect reports.
Jan 2010 - Present
15 years 7 monthsZürich, Switzerland
Interim manager, consultant, facilitator
Hans Spichiger Business Excellence Services GmbH
- Project Management with focus on trouble shooting & customer care and/or 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.
Jan 2009 - Dec 2010
2 yearsConsultant
Business Excellence Services
- Supporting quality initiatives in Medical Device Industry.
- Assessments and Audits for Manufacturers as well as on suppliers’ sites as a consultant of newly set up own company “Business Excellence Services”.
Jan 2007 - Dec 2009
3 yearsNidau, Switzerland
Head of Quality Management
forteq Healthcare
- 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 extension, including the Qualification and Validation management.
- Responsible for the Quality Assurance and - Control department, including product release as well as for 20 direct- and indirect-reports.
- Management system-, Document-, Compliance-, CAPA-, Change- and Complaint responsibility according to US- and EU-Medical-Device- & GMP-Regulations.
Jan 2003 - Dec 2005
3 yearsAu, Switzerland
Quality Manager
ESCATEC
- Quality Manager including HSE responsibilities for the internationally active medical devices and measurement systems Electronics Contract PCB-Manufacturer (ISO 9001; 13485; 14001).
Jan 2001 - Dec 2002
2 yearsKüsnacht, Switzerland
Consultant; 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 e.g., at Kaleidos-AKAD or IFA: “Master of Business Process Engineering.”
Jan 1999 - Dec 2001
3 yearsHorgen, Switzerland
Quality Manager
Schweiter Technologies
- Quality Manager in the international logistics network of this machinery manufacturer.
- People management and strategic outsourcing projects.
Jan 1999 - Dec 2001
3 yearsZürich, Switzerland
Business Organizer
Telekurs-Payserv
- Business Organizer in the largest computer center owned by the Swiss banks.
Jan 1994 - Dec 1999
6 yearsZürich, Switzerland
ABB Customer Focus Manager (Quality- and Environmental Management, Security, Safety, Training)
ABB
- Project management in the setting up of management systems (ISO 9001; 14001, Health & Safety), in three languages at 14 sites.
- Leading Project Manager for certification, according to ISO standards.
- Auditing and Assessments according to EFQM within the ABB Group.
- Project Management Trainer for a group of 80 Project Manager’s.
- Managing with support of 7 assistants, the training and development around 120 apprentices at 14 locations throughout Switzerland.
Jan 1986 - Dec 1994
9 yearsWikon, Switzerland
Project Manager
Hunkeler Entsorgungssysteme
- Build-up and management of a team executing the electrical engineering for the construction of bulk goods installations.
- CE-documentation of complex shredding systems in a waste incineration plants.
- 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 design and development of the equipment control.
Jan 1977 - Dec 1986
10 yearsAarburg, Switzerland
Apprenticeship in Electrical installations and industrial control technician for power electronics including vocational
CKW and Weber & Cie AG
- Apprenticeship in Electrical installations and industrial control technician for power electronics including vocational baccalaureate.
Summary
40 years of industry experience - 20 of them in medical technology/IVD/pharma. 25 years of quality management - 20 of them in management positions.
40 years of industry experience - 20 of them in medical technology/IVD/pharma. 25 years of quality management – 20 of them in leadership roles.
40 years of industry experience - 20 of them in medical technology/IVD/pharma. 25 years of quality management - 20 of them in leadership roles.
Languages
German
NativeEnglish
AdvancedFrench
Advanced Education
Oct 1977 - Jun 1986
CKW, Reiden/ Luzern and Weber & Cie AG, Aarburg
Electrical Installations and Industrial Control Technician for Power Electronics Including Vocational Baccalaureate · Switzerland
Certifications & licenses
CPMS Certified Professional for Medical Software
CPMS
EOQ Business Excellence Assessor
EOQ
EOQ Environmental System Manager
EOQ
EOQ Quality System Manager
EOQ
EOQ Quality-Auditor
EOQ
EOQ TQM-Leader
EOQ
Medical Mountains Validation Manager
Medical Mountains
PTS Expert of GMP
PTS
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