Hans Spichiger-Interim Manager, Consultant, Facilitator
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Experience
Interim Manager, Consultant, Facilitator
Business Excellence Services GmbH
Interim manager, consultant, facilitator
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; free auditor
Since 2016, working for various accredited organizations as a freelance auditor regarding systems according to ISO 13485 and ISO 9001
2023-2024: Medical device product development, supply-chain and regulatory set-up with regard to a medical device re-engineering/launch and manufacturing
2023-2024: Project trouble shooter & customer care in the European aerospace industry within precision optics systems manufacturing; project risk and validation management including software validation
2022: Validation (FMEA, IQ OQ, PQ) management assigned with design and process risk assessment of complex electrical (IEC60601-1) mechatronics robots for MDR approval following ISO 14971
2022: Interim head of QM in aluminum-foil deep drawing process improvement; people and international Nespresso supplier quality management
2021-2022: Cytiva Cell Therapy greenfield project; assigned with design and implementation support of a certification, validation, GMP commissioning strategy for the technical infrastructure, e.g., clean rooms
2020-2021: Interim QA-Leader in Denmark assigned with the software release, manufacturing and distribution of Class IIb laser equipment for Candela, including international notified body and manufacturing transfer project
2020: Quality support and interim quality management for a manufacturer in the IVD test equipment supply chain and dialysis supplies in Bavaria
2018-2020: Expert/SME in Q-Management/Q-Engineering for orthopedic and arthroplasty device and tool production: turning, milling, cleaning, surface treatment and sterile packaging
2017: Re-engineering of the Medela product development process regarding cGMP 21CFR820.30/ISO 13485:2016 and MDR design control requirements for soft and hardware design regarding Class IIb pumps
2017: MDSAP preparation support and mock-audit coaching
2016: Interim senior QE-Expert for Maquet extracorporeal circulation devices manufacturing as ISO 14971 risk and change management expert in a Roche CAPA remediation and compliance project of IVD blood analyzers/gas sensor production
2016-2017: Orthopedic and arthroplasty implants design history file (DHF) review regarding compliance to 21 CFR 820.30 design control requirements
2015: Assigned by Novartis with design control for a new parenteral drug delivery system; manufacturability assessments during design evaluation; assessing potential plastic injection molding and/or high-volume assembly contractors in Europe and the US
2014: Assessing/auditing metallurgy process validation (IQ/OQ/PQ) of Zimmer contract manufacturers around Europe for FDA audit readiness; Depuy-Synthes subject matter expert (SME)
2013-2014: CAPA-8D process reengineering and setting in place/training new EtQ software tools; coaching of project and product managers in working through individual CAPAs; remediation of global legacy CAPAs; supporting complaint and field action (FSCA) management
2012-2013: QA/RA Manager at Sias AG for in vitro diagnostics (IVD) liquid handling robots manufacturing; led small team for electrical safety CE/CB scheme product approvals; QMS, change and CAPA management
2011-2012: Site Quality Manager at Medtronic for drug eluting balloon and Nitinol stent-catheter manufacturing; quality operations including Q-engineering and control; led 15 direct and indirect reports
2009-2010: Supported quality initiatives in medical device industry; assessments and audits for manufacturers and suppliers as a consultant of Business Excellence Services
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 qualification and validation management
- Responsible for the quality assurance and control department, including product release; managed 20 direct and indirect reports
- Management system, document, compliance, CAPA, change and complaint responsibility according to US and EU medical device and GMP regulations
Quality Manager
ESCATEC
- Quality manager including HSE responsibilities for an internationally active medical devices and measurement systems electronics contract PCB manufacturer (ISO 9001; 13485; 14001)
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”
Business Organizer
Schweiter Technologies
- Business organizer in the largest computer center owned by the Swiss banks
Quality Manager
Telekurs-Payserv
- Quality manager in the international logistics network of a machinery manufacturer; people management and strategic outsourcing projects
Customer Focus Manager
ABB
- Project management in setting up management systems (ISO 9001; 14001; Health & Safety) in three languages at 14 sites
- Led certification projects according to ISO standards
- Auditing and assessments according to EFQM within the ABB Group
- Project management trainer for a group of 80 project managers
- Managed training and development of around 120 apprentices at 14 locations with support of seven assistants
Project Manager
Hunkeler Entsorgungssysteme
- Built and managed a team executing the electrical engineering for construction of bulk goods installations
- CE documentation of complex shredding systems in waste incineration plants
- Executed extensive customer trainings in Italy and Geneva
- Validation/qualification of large paper processing equipment in banks, printing industry, and recyclers
- Project management and rollout of computer aided engineering (CAE) and PLC system application for design and development of equipment control
Apprentice Electrical Installations and Industrial Control Technician
CKW; Weber & Cie AG
- Apprenticeship in electrical installations and industrial control technician for power electronics including vocational baccalaureate
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Manufacturing, Healthcare, Aerospace and Defense, Utilities, Energy, and Banking and Finance.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Project Management, Supply Chain Management, Operations, Product Development, and Human Resources.
Skills
- Process-/ Project- & Supply Chain-Management, Design- & Process Validation; Benchmarking
- Management Systems According To Iso 9001, 13485, 14001, Cgmp - 21cfr820/803/210/211
- Risk-, Complaint-, Deviation-, Capa-, Change-Management, Equipment Qualification
- Device Design & -Control, Risk Analysis (E.G., Iso 31000 & 14971), Root Cause Analysis
- Document Management, Quality Control, Product- Packaging, Sterilization And Release
- Safety- And Health-Management, Lean Managemen, Excellence Programs
- Coaching, Internal Training, Team Development, Problem Solution Methods
- Assessment, Auditing, Supplier Audits
Languages
Education
CKW / Weber & Cie AG
Apprenticeship, vocational baccalaureate · Electrical installations and industrial control technician for power electronics · Aarburg, Switzerland
Certifications & licenses
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
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Hans is based in Zürich, Switzerland and can operate in on-site, hybrid, and remote work models.
Hans speaks the following languages: German (Native), English (Advanced), French (Advanced).
Hans has at least 47 years of experience. During this time, Hans has worked in at least 8 different roles and for 9 different companies. The average length of individual experience is 5 years and 3 months. Note that Hans may not have shared all experience and actually has more experience.
Based on recent experience, Hans would be well-suited for roles such as: Interim Manager, Consultant, Facilitator, Head of Quality Management, Quality Manager.
Hans's most recent position is Interim Manager, Consultant, Facilitator at Business Excellence Services GmbH.
In recent years, Hans has worked for Business Excellence Services GmbH.
Hans is most experienced in industries like Manufacturing, Healthcare, and Aerospace and Defense. Hans also has some experience in Utilities, Energy, and Banking and Finance.
Hans is most experienced in business areas like Quality Assurance, Project Management, and Supply Chain Management. Hans also has some experience in Operations, Product Development, and Human Resources.
Hans has recently worked in industries like Aerospace and Defense, Healthcare, and Manufacturing.
Hans has recently worked in business areas like Project Management, Quality Assurance, and Supply Chain Management.
Hans attended CKW / Weber & Cie AG for Electrical installations and industrial control technician for power electronics.
Hans has 8 certificates. Among them, these include: Cpms Certified Professional For Medical Software, Eoq Business Excellence Assessor, and Eoq Environmental System Manager.
The availability of Hans needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 7 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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