Recommended expert

Veit Maager

Quality Manager, Regulatory Affairs, Risik and Validation Mangement

Veit Maager
Thayngen, Switzerland

Experience

Jul 2025 - Present
9 months
Schaffhausen, Switzerland

Test Method Development and Validation Engineer

Gebr. Renggli AG

  • Test method validation for destructive testing (peel-force testing) according to ASTM F88/F88M
Nov 2023 - Present
2 years 5 months
Schaffhausen, Switzerland

Quality Management System Consultant

Medipack AG

  • Update of quality management system
  • Process validation
  • Statistics and statistical analysis
  • Regulatory requirements (regulatory affairs)
  • Method validation and process for medical device packaging systems (sterile barrier systems)
Jul 2021 - Present
4 years 9 months
Schaffhausen, Switzerland

Project Manager MDD→MDR Transition

Karl Storz Endoscopy Production GmbH

  • Transfer technical documentation (DHF/DMR) from MDD to MDR compliance for endoscopy products (devices and single-use)
  • Test method development and validation for destructive (peel-force testing) and non-destructive testing (tightness-testing on tubing set)
  • Verification and validation of sealing seams within process development at the supplier
Jul 2021 - Apr 2025
3 years 10 months
Wolhusen, Switzerland

Qualification and Process Validation Engineer

Geistlich Pharma AG

  • Qualification and process-validation of packaging line (Form-Fill-Seal) for temporary sterile products for medical devices
  • Establish form-fill-seal packaging line for small implantable medical device Class I and II
  • Plan packaging performance and stability simulations based on ISO 11607-1, ISO 11607-2
Feb 2018 - Jun 2021
3 years 5 months
Baar, Switzerland

Packaging Development Engineer

Medela

  • Establish and maintain packaging development process for medical devices
  • Plan and coordinate design verification of packaging system performance and stability (ISO 11607-1, ISO 11607-2)
  • Arrange and perform notifications of change to notified body for terminally sterile products
  • Design control/change management including risk management evaluation
Oct 2015 - Dec 2017
2 years 3 months
Winterthur, Switzerland

Global Packaging Project Manager

Zimmer Biomet

  • Align packaging systems and accomplish full compliance with international standards and regulatory requirements (FDA 21 CFR Part 820, MDD)
  • Design control/change management for change activities including risk management coordination
Jun 2014 - Sep 2015
1 year 4 months
Winterthur, Switzerland

Interim Packaging Development Engineer

Zimmer Biomet

  • Packaging development remediation and packaging system changes
  • Packaging system performance verification and shelf life verification planning according to FDA 21 CFR Part 820 and MDD 93/42 EEC
Dec 2012 - May 2014
1 year 6 months
Schaffhausen, Switzerland

Interim Qualification and Validation Manager

Medipack AG

  • Customer packaging validation
  • Process validation including risk management
  • Sterilization validation (ISO 11135, ISO 11137)
  • Medical packages (pouches and blister) for medical devices Class I – III
Apr 2012 - Jun 2013
1 year 3 months
Risch-Rotkreuz, Switzerland

Consultant Qualification Customized Test Equipment

ROCHE Diagnostics International

  • Development and production of diagnostic test equipment (blood-gas sensors, no medical device class)
Jan 2012 - Jan 2012
1 month
Menlo Park, United States

Consultant Medical Quality Engineering

Memry

  • Measurement technologies
  • Process engineering
  • Validation process
  • Nitinol semi-finished products
Sep 2011 - Dec 2011
4 months
Frauenfeld, Switzerland

Interim Quality Engineer

Medtronic Invatec

  • Validation of processes and test methods
  • Verifications
  • Process engineering in cardiovascular therapies – catheter and Nitinol stent production (Medical Devices Class III)
Oct 2010 - Nov 2011
1 year 2 months
Schaffhausen, Switzerland

Deputy Quality Assurance Manager and Validation Officer

Georg Fischer PipingSystems - Medical Division

  • QM process development (qualification and validation, risk management, CAPA management)
  • Equipment qualification and process validation in production of medical devices (Class I)
Aug 2010 - Nov 2010
4 months
Oberdiessbach, Switzerland

Interim Quality Manager

Remp/Nexus AG

  • Renew QM system including risk management, audit process, CAPA process (no medical device class, only storage equipment/sample management systems)
Jun 2010 - Present
15 years 10 months
Hallau, Switzerland

Consultant – Quality Management

Maager Quality Management GmbH

  • Consulting on all quality management issues
  • Building and monitoring quality management systems (ISO 9001:2008, ISO 13485:2003/AC2007, ISO 13485:2016)
  • Risk management
  • Design/process qualification, verification and validation
Jul 2009 - Dec 2009
6 months
Solothurn, Switzerland

Quality/Product Manager

Roth Décolletage AG / Roth Medical AG

  • Reorient quality management system to align with medical device requirements (ISO 13485:2003)
  • Integrate development, validation, and supplier quality management
  • Train employees on quality issues
  • Handle complaints
  • Product management
Jul 2007 - Jun 2009
2 years
Burgdorf, Switzerland

Quality Assurance Manager, Validation Officer

Disetronic Medical Systems AG

  • Validation Officer
  • Co-project leader for quality in development projects
  • Ensure compliance throughout the projects
  • Coordinate all quality issues during projects
  • Responsible for addressing supplier quality queries
  • Plan and conduct supplier audits across Europe
  • Supplier evaluation, monitoring and development
Dec 2004 - Jun 2007
2 years 7 months
Birkenfeld, Germany

Head of Quality & Regulatory Affairs, Vice President

Vascotube GmbH

  • Plan and handle all quality issues within the company
  • Plan and conduct internal audits
  • Plan all inspections
  • Supervise all quality results
  • Manage corrective and preventive actions
  • Risk management
  • Reporting
  • Complaint handling
  • Lead all validation activities
Sep 2000 - Nov 2004
4 years 3 months
Pforzheim, Germany

Certified Engineer, Quality Assurance Manager

G. Rau GmbH & Co. KG

  • Quality planning and inspection planning (tube, wire, and double production)
  • Inspection planning (NiTi alloy, tube, and wire medical devices)
  • Defect analysis
  • Measurement equipment management
  • Approval of certifications (according to ISO 10204 3.1)
  • Complaint handling (German, English)
  • Reporting (German, English)
  • Customer contact in the USA

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Healthcare (25 years), Manufacturing (10.5 years), and Pharmaceutical (4 years).

Healthcare
Manufacturing
Pharmaceutical

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (25 years), Project Management (7 years), Product Development (6 years), Production (2.5 years), and Research and Development (0.5 years).

Quality Assurance
Project Management
Product Development
Production
Research and Development

Summary

  • Success in building industrial quality management systems
  • Certain to arrange and execute audits (internal and supplier)
  • Knowledge in quality statistics and process development
  • Skilled in using quality management systems and quality management tools
  • Long experience in development of terminally sterile medical device packaging
  • Intelligence in conversations and negotiations with customers
  • Skilled in training employees in quality issues
  • Experience in qualification of equipment and validation of processes
  • Smart in usage of OFFICE-tools (WORD, EXCEL, OUTLOOK, POWERPOINT)
  • Experience in packaging development of medical devices
  • Experience in shape memory alloy NiTi, behavior, production and products
  • Knowledge of ASTM-/ ASQ-standards for statistics and medical device material
  • Dedicated and able to work under pressure, always interested in learning new technologies and using well known things

Skills

  • Specialized Knowledge In Law Fda 21cfr Part 820, 21cfr Part 11, As Well Cgmp-guidance Documents

  • Packaging Development For Medical Devices Class I, Ii And Iii For Temporary Sterile Devices Acc. Iso 11607-1/-2

  • Validation Of Processes And Qualification Of Equipment

  • Risk Management According To Iso 14971

  • Part-leadership Of Development-projects

  • Material Knowledge In Steel (Cold Rolling, Forging, Tube Drawing), Special Alloys (Niti-alloys, Cu-alloys)

  • Metallographic Knowledge

  • Specialized Knowledge In Non-destructive Testing And Destructive Testing

  • Control Of Inspection, Measuring And Test Equipment

  • Experience In Process Development

  • Experience In Equipment Qualification

  • Experience In Process Validation

  • Experience In Risk Management

  • Experience In Medical Device Regulations

  • Experience In Clean-room Area Production

  • Experience In Internal And Supplier Auditing

  • Sample Size Planning

  • Auditor (Eoq & Dgq-tga)

  • Quality Manager Dgq (Qm)

  • Quality Representative Dgq (Qb)

  • Quality Technician Dgq (Q Ii)

  • Office-tools: Word, Excel, Outlook, Powerpoint, Visio, Project

  • Caq-systems: Ibs, Quipsy, Babtec

  • Sap R3 User-knowledge

Languages

German
Native
English
Advanced

Education

Aug 1996 - Jul 2000

Robert Bosch Vocational College, Technical School, Duisburg-Hamborn

State-certified Materials Technician, Certified Engineer (Materials) · Materials Engineering, Material technologies · Duisburg, Germany

Aug 1988 - Jul 1991

Kaltwalzwerk R. Mendritzki GmbH & Co. KG

Vocational training as materials tester, materials inspector - physics · Materials tester, materials inspector - physics · Plettenberg, Germany

Certifications & licenses

Certified Engineer, Material Technologies

Materials Inspector

Certified Calibration Technician

Profile

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Frequently asked questions

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

Where is Veit based?

Veit is based in Thayngen, Switzerland.

What languages does Veit speak?

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

How many years of experience does Veit have?

Veit has at least 25 years of experience. During this time, Veit has worked in at least 18 different roles and for 16 different companies. The average length of individual experience is 1 year and 5 months. Note that Veit may not have shared all experience and actually has more experience.

What roles would Veit be best suited for?

Based on recent experience, Veit would be well-suited for roles such as: Test Method Development and Validation Engineer, Quality Management System Consultant, Project Manager MDD→MDR Transition.

What is Veit's latest experience?

Veit's most recent position is Test Method Development and Validation Engineer at Gebr. Renggli AG.

What companies has Veit worked for in recent years?

In recent years, Veit has worked for Gebr. Renggli AG, Medipack AG, Karl Storz Endoscopy Production GmbH, Geistlich Pharma AG, and Medela.

Which industries is Veit most experienced in?

Veit is most experienced in industries like Healthcare, Manufacturing, and Pharmaceutical.

Which business areas is Veit most experienced in?

Veit is most experienced in business areas like Quality Assurance (QA), Project Management, and Product Development. Veit also has some experience in Production/Manufacturing and Research and Development (R&D).

Which industries has Veit worked in recently?

Veit has recently worked in industries like Healthcare, Manufacturing, and Pharmaceutical.

Which business areas has Veit worked in recently?

Veit has recently worked in business areas like Quality Assurance (QA), Project Management, and Product Development.

What is Veit's education?

Veit holds a Doctorate in Materials tester, materials inspector - physics from Kaltwalzwerk R. Mendritzki GmbH & Co. KG.

Does Veit have any certificates?

Veit has 3 certificates. These include: Certified Engineer, Material Technologies, Materials Inspector, and Certified Calibration Technician.

What is the availability of Veit?

Veit will be available full-time from March 2026.

What is the rate of Veit?

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

How to hire Veit?

To hire Veit, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

1400
1050
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Market avg: 1200-1360 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.