Hans Spichiger - Product Development Team Member

Q: Where is Hans based?

Hans is based in Zürich, Switzerland .

Q: What languages does Hans speak?

Hans speaks the following languages: German (Native), English (Advanced), French (Advanced) .

Q: How many years of experience does Hans have?

Hans has at least 19 years of experience. During this time, Hans has worked in at least 21 different roles and for 20 different companies . The average length of individual experience is 1 year and 11 months . Note that Hans may not have shared all experience and actually has more experience.

Q: What is Hans's latest experience?

Hans's most recent position is Product Development Team Member at Smell Discettes GmbH .

Q: What companies has Hans worked for in recent years?

In recent years, Hans has worked for Smell Discettes GmbH , Swissoptic/Jenoptik , Hocoma , Business Excellence Services GmbH , and Cytiva .

Q: Which industries is Hans most experienced in?

Hans is most experienced in industries like Healthcare , Manufacturing , and Aerospace and Defense . Hans also has some experience in Pharmaceutical , Biotechnology , and Food and Beverage .

Q: Which business areas is Hans most experienced in?

Hans is most experienced in business areas like Quality Assurance , Project Management , and Product Development . Hans also has some experience in Audit , Production , and Supply Chain Management .

Q: Which industries has Hans worked in recently?

Hans has recently worked in industries like Healthcare , Manufacturing , and Aerospace and Defense .

Q: Which business areas has Hans worked in recently?

Hans has recently worked in business areas like Quality Assurance , Project Management , and Product Development .

Recommended expert

Zürich, Switzerland

Experience

Jan 2024 - Dec 2025

2 years

Product Development Team Member

Smell Discettes GmbH

Supply chain and regulatory setup for medical device re-engineering, launch and manufacturing ramp-up

Jan 2023 - Dec 2024

2 years

Project Trouble Shooter and Customer Care

Swissoptic/Jenoptik

Trouble shooting and customer care in precision optics systems manufacturing and coating
Risk and validation management including software validation

Jan 2022 - Dec 2022

1 year

Validation Manager

Hocoma

Managed FMEA, IQ/OQ, PQ
Conducted design and process risk assessment of complex electrical (IEC 60601-1) mechatronics robots for MDR approval following ISO 14971

Jan 2021 - Dec 2022

2 years

Interim Head of Quality Management

Business Excellence Services GmbH

Improved aluminum-foil deep drawing process
Managed people and international supplier quality for Nespresso

Jan 2021 - Dec 2022

2 years

Quality and Validation Consultant

Cytiva

Supported design and implementation of certification, validation and GMP-commissioning strategy for technical infrastructure including clean rooms in cell therapy greenfield project

Jan 2020 - Dec 2021

2 years

Denmark

Interim QA Leader

Candela-Ellipse

Managed software release, manufacturing and distribution of Class IIb laser equipment
Coordinated international notified body and manufacturing transfer project

Jan 2020 - Dec 2020

1 year

Germany

Quality Support and Interim Quality Manager

Ritter

Supported quality management in IVD test equipment and dialysis supplies supply chain

Jan 2018 - Dec 2020

3 years

Expert / SME in Quality Management and Engineering

Zimmer

Managed quality engineering for supply-chain orthopedic and arthroplasty device and tool production including turning, milling, cleaning, surface treatment and sterile packaging

Jan 2017 - Dec 2017

1 year

Product Development Process Consultant

Medela

Re-engineered product development process to comply with cGMP 21 CFR 820.30, ISO 13485:2016 and MDR design control requirements for soft- and hardware design of Class IIb pumps

Jan 2016 - Dec 2024

9 years

Freelance Auditor

Various Accredited Organizations

Auditing systems according to ISO 13485 and GMP/ISO 9001

Jan 2016 - Dec 2017

2 years

Design Control Reviewer

Stryker

Reviewed design history file for orthopedic and arthroplasty implants for compliance with 21 CFR 820.30

Jan 2016 - Dec 2016

1 year

Senior Quality Engineering Expert

Maquet

Provided risk and change management for extracorporeal circulation devices (oxygenator)
Interim senior quality engineering support

Jan 2016 - Dec 2016

1 year

Design Control Consultant

Novartis

Advised on design control for new drug delivery system

Jan 2016 - Dec 2016

1 year

Risk and Compliance Expert

Roche

Remediated CAPA and ensured compliance in IVD blood analyzers and gas sensor production

Jan 2014 - Dec 2014

1 year

Subject Matter Expert

DePuy Synthes

Provided SME support for orthopedic and arthroplasty device metallurgy processes

Jan 2014 - Dec 2014

1 year

Validation Consultant

Zimmer Contract Manufacturers

Conducted IQ/OQ/PQ validation for multiple potential and existing contract manufacturers for FDA audit readiness

Jan 2012 - Dec 2013

2 years

QA/RA Manager

Sias AG / Tecan

Managed QA, RA and QMS for in vitro diagnostics liquid handling robot manufacturing
Led electrical safety approvals (CE/CB Scheme)
Oversaw change and CAPA management

Jan 2011 - Dec 2012

2 years

Site Quality Manager

Medtronic

Managed quality operations, engineering and control for drug eluting balloon and nitinol stent catheter manufacturing
Led team of 15 direct and indirect reports

Jan 2010 - Present

16 years 3 months

Interim Manager, Consultant, Facilitator

Business Excellence Services GmbH

Project management with focus on trouble shooting and customer care and/or product development and reengineering; risk, validation, supply chain, quality and regulatory management (MDR/IVDR)
Experience within medical device, packaging, aerospace, small and large equipment, optical and electrical systems, metal, plastics and glass

Jan 2009 - Dec 2010

2 years

Quality Consultant

Business Excellence Services

Supported quality initiatives in the medical device industry through assessments and audits for manufacturers and suppliers

Jan 2007 - Dec 2009

3 years

Nidau, Switzerland

Head of Quality Management

forteq Healthcare

Led quality in manufacturing combined medical devices for GlaxoSmithKline’s asthma treatment program including plastic injection, printing and micro-assembling
Managed clean room extension qualification and validation
Responsible for QA/QC and product release with 20 direct and indirect reports
Oversaw document, CAPA, change and complaint management according to US and EU medical device and GMP regulations

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Healthcare, Manufacturing, Aerospace and Defense, Pharmaceutical, Biotechnology, and Food and Beverage.

Healthcare

Manufacturing

Aerospace and Defense

Pharmaceutical

Biotechnology

Food and Beverage

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Project Management, Product Development, Audit, Production, and Supply Chain Management.

Quality Assurance

Project Management

Product Development

Audit

Production

Supply Chain Management

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-, Change-management Equipment-/ Product-qualification
Device Design & -Control, Risk Analysis (E.g., Iso 31000 & 14971), Root Cause Analysis (E.g. Swot, Fmea, 5-why, Ishikawa, Msa)
Document Management (Sops), Quality Control (-Plans), Product- Packaging, Sterilization And Release
Safety- And Health-management, Lean Managemen, Excellence Programs
Coaching, Internal Training, Team Development, Problem Solving Methods (E.g. 8d, Capa, Pareto)
Assessment, (System-, Product-, (Layered-process-) Auditing, Supplier Audits
Erp-systems/ Pps As E.g. Sap, Jd Edwards, Sage

Languages

German

Native

English

Advanced

French

Advanced

Education

Electrical Engineering studies

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

Total positions 21

Experience in Healthcare 19 y

Avg length 2 y 8 m

Longest experience 16 y 2 m

Global Experience

Countries worked in 3 (Denmark, Germany, Switzerland)

Primary country Denmark

Expertise

Recent roles Product Development Team Member, Project Trouble Shooter and Customer Care, Validation Manager

Main industries Healthcare, Manufacturing, Aerospace and Defense

Main business areas Quality Assurance, Project Management, Product Development

Qualifications

Highest degree Bachelor

Certifications earned 8

Profile

Created

March 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Hans based?

Hans is based in Zürich, Switzerland.

What languages does Hans speak?

Hans speaks the following languages: German (Native), English (Advanced), French (Advanced).

How many years of experience does Hans have?

Hans has at least 19 years of experience. During this time, Hans has worked in at least 21 different roles and for 20 different companies. The average length of individual experience is 1 year and 11 months. Note that Hans may not have shared all experience and actually has more experience.

What roles would Hans be best suited for?

Based on recent experience, Hans would be well-suited for roles such as: Product Development Team Member, Project Trouble Shooter and Customer Care, Validation Manager.

What is Hans's latest experience?

Hans's most recent position is Product Development Team Member at Smell Discettes GmbH.

What companies has Hans worked for in recent years?

In recent years, Hans has worked for Smell Discettes GmbH, Swissoptic/Jenoptik, Hocoma, Business Excellence Services GmbH, and Cytiva.

Which industries is Hans most experienced in?

Hans is most experienced in industries like Healthcare, Manufacturing, and Aerospace and Defense. Hans also has some experience in Pharmaceutical, Biotechnology, and Food and Beverage.

Which business areas is Hans most experienced in?

Hans is most experienced in business areas like Quality Assurance, Project Management, and Product Development. Hans also has some experience in Audit, Production, and Supply Chain Management.

Which industries has Hans worked in recently?

Hans has recently worked in industries like Healthcare, Manufacturing, and Aerospace and Defense.

Which business areas has Hans worked in recently?

Hans has recently worked in business areas like Quality Assurance, Project Management, and Product Development.

What is Hans's education?

Hans holds a Bachelor in Electrical Engineering studies.

Does Hans have any certificates?

Hans has 8 certificates. Among them, these include: CPMS Certified Professional For Medical Software, EOQ Business Excellence Assessor, and EOQ Environmental System Manager.

What is the availability of Hans?

Hans will be available full-time from March 2026.

What is the rate of Hans?

Hans's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.