Hans Spichiger

interim Manager & Medical Device Expert

Zürich, Switzerland

Experience

Jan 2024 - Dec 2025
1 year

Medical 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 2022 - Dec 2025
2 years

Project 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 2021 - Dec 2022
1 year

Interim 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 2021 - Dec 2022
1 year

Validation 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 2020 - Dec 2022
2 years

Consultant 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 years
Denmark

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 year
Germany

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 years

Expert/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 2016 - Dec 2017
1 year

Consultant for MDSAP Preparation Support and Mock-Audit Coaching

Hans Spichiger Business Excellence Services GmbH

  • MDSAP Preparation Support and Mock-Audit Coaching.
Jan 2016 - Dec 2017
1 year

Consultant 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 2015 - Present
9 years 7 months
Zürich, 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 2015 - Dec 2017
2 years

Consultant 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 2015 - Dec 2016
1 year

Interim 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 year

Design 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 2015
1 year

Auditor 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 2015
2 years

Subject 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 2011 - Dec 2014
2 years

QA/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 2010 - Dec 2013
2 years

Site 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 2009 - Present
15 years 7 months
Zürich, 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 years

Consultant

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 years
Nidau, 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 years
Au, 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 2003
2 years
Küsnacht, 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 1998 - Dec 2002
3 years
Horgen, Switzerland

Quality Manager

Schweiter Technologies

  • Quality Manager in the international logistics network of this machinery manufacturer.
  • People management and strategic outsourcing projects.
Jan 1998 - Dec 2002
3 years
Zürich, Switzerland

Business Organizer

Telekurs-Payserv

  • Business Organizer in the largest computer center owned by the Swiss banks.
Jan 1993 - Dec 1999
6 years
Zürich, 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 years
Wikon, 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 1976 - Dec 1987
10 years
Aarburg, 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
Native
English
Advanced
French
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