Hans Spichiger
Interim Manager, Consultant, Facilitator
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
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
Profile
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