Kai Jeske - Freelancer / QM Consultant

Q: Where is Kai based?

Kai is based in Hamburg, Germany and can operate in on-site , hybrid , and remote work models.

Q: What languages does Kai speak?

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

Q: How many years of experience does Kai have?

Kai has at least 21 years of experience. During this time, Kai has worked in at least 9 different roles and for 10 different companies . The average length of individual experience is 2 years and 1 month . Note that Kai may not have shared all experience and actually has more experience.

Q: What is Kai's latest experience?

Kai's most recent position is Freelancer / QM Consultant at ValiQuali.de .

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

In recent years, Kai has worked for ValiQuali.de .

Q: Which industries is Kai most experienced in?

Kai is most experienced in industries like Healthcare , Manufacturing , and Pharmaceutical . Kai also has some experience in Biotechnology and Energy .

Q: Which business areas is Kai most experienced in?

Kai is most experienced in business areas like Quality Assurance , Project Management , and Production . Kai also has some experience in Product Development , Research and Development , and Operations .

Q: Which industries has Kai worked in recently?

Kai has recently worked in industries like Healthcare .

Q: Which business areas has Kai worked in recently?

Kai has recently worked in business areas like Project Management and Quality Assurance .

Recommended expert

Hamburg, Germany

Experience

Dec 2020 - Present

5 years 4 months

Freelancer / QM Consultant

ValiQuali.de

Qualification of production facilities and process validations of a new production line for the manufacture of implants incl. URS, IQ, OQ and PQ
Quality remediation project (optimization of procedures, SOP and test methods and work instructions incl. change management)
Project lead for a test method validation
CAPA management
Non-conformance management
Gap analysis

Dec 2019 - Mar 2020

4 months

Norderstedt, Germany

Quality Engineer in Quality Operations / Validations

Waldemar Link GmbH & Co. KG

Validation of cleaning processes (Production)
Efficacy validation of cleaning, disinfection and sterilization of implants and reusable instruments
Cleanroom validation
Monitoring
Data integrity and FDA 21 CFR Part 11 compliance
Non-conformance responsible for monitoring
Risk management (especially pFMEA) for cleaning processes and process water treatment

Dec 2013 - Oct 2019

5 years 11 months

Norderstedt, Germany

Quality Engineer in Quality Operations

Johnson & Johnson Medical GmbH

Project lead: Outsourcing of an internal production process and design change
Core team member of quality for international strategic projects
Responsible for all quality concerns of needle manufacturing and finished good production
Qualification, process and test method validation
Sampling incl. sample sizes for validation and production
Monitoring
Data integrity and FDA 21 CFR Part 11 compliance
Non-conformance (especially risk assessment, bounding and product disposition)
Risk management (especially pFMEA) production processes
CAPA and internal audit
Audit readiness
EHS&S responsible for quality

Mar 2012 - Oct 2013

1 year 8 months

Hamburg, Germany

Development Engineer in R&D / CDS

Olympus Winter & Ibe GmbH

Efficacy validation of cleaning, disinfection and sterilization of reusable instruments (endoscopes and hand instruments)
Biocompatibility
Material-compatibility for reprocessing

Aug 2011 - Dec 2011

5 months

Berlin, Germany

Sales and Project Engineer Biogas Production

HeGo Biotec GmbH

Process engineering; desulfurization of biogas
Sale of desulfurization substances

May 2010 - May 2011

1 year 1 month

Berlin, Germany

Pharmaceutical Process Engineer in R&D

Biomet Deutschland GmbH

Process engineering; process development for a combination product
Process validation and qualification of equipment

Jun 2007 - Dec 2009

2 years 7 months

Hamburg, Germany

Freelancer Quality Assurance

K.-W. Pfannenschmidt GmbH

Feb 2002 - Feb 2004

2 years 1 month

Hamburg, Germany

Chemical Laboratory Assistant in Quality Control

Dental Material Gesellschaft mbH

Apr 2001 - Jan 2002

10 months

Buxtehude, Germany

Community Service in the Kitchen of a Hospital

Elbe Kliniken Stade-Buxtehude

Feb 2000 - Jan 2001

1 year

Hamburg, Germany

Chemical Laboratory Assistant in Quality Control

Beiersdorf AG, Division Medical

Industry Experience

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

Experienced in Healthcare, Pharmaceutical, Manufacturing, Biotechnology, and Energy.

Healthcare

Pharmaceutical

Manufacturing

Biotechnology

Energy

Business Area Experience

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

Experienced in Quality Assurance, Project Management, Production, Product Development, Research and Development, and Operations.

Quality Assurance

Project Management

Production

Product Development

Research and Development

Operations

Skills

Very Good Knowledge Of Ms Office Including Ms Visio And Ms Project
Operating Systems: All Ms Windows Versions
Basic Knowledge Of Programming With Visual Basic, C And C ++
Cad: Autodesk Inventor 10 And Autocad
Sap And Jd Edwards Enterpriseone (Oracle) / Erp Software
Lims And Other Laboratory Data And Test Equipment Software
Very Good Knowledge Of Multimedia And Internet
Project Manager: Design Change Of A Medical Device Due To Change Of A Raw Material And Production Process (Incl. Supplier Qualification, Validation, Change Management, Dhf, Etc.)
Project Manager: Outsourcing Of An Internal Production Process (Medical Device) To An External Manufacturer (Incl. Audit, Validation, Change Management, Dhf, Etc.)
Core Team Member In The Project To Set Up A New Production Facility And New Production Lines For Medical Devices
Responsibility For Occupational Health And Safety In The Area Of Quality (Including Chemical And Physical Laboratories, Job Safety Analyzes, Etc.)
Tüv Certified Quality Management Officer And Quality Manager According To Iso 9001 And Qm-auditor According To Iso 19011
Advanced Knowledge Of Quality Management In Particular Iso 9001, Iso 13485, Iso 10993, Iso 14971, Regulations For Reprocessing And Clean Rooms, Ich, Mdd, Mdr, Fda 21 Cfr 820, Fda 21 Cfr 11, Gmp, Cgmp, Glp, Gdocp, Gxp, Etc.
Extended Knowledge Of Scientific-regulatory Writing Through Participation In A Seminar On The Subject With Prof. Dr. Markus Veit
Advanced Knowledge In Dealing With International Pharmacopoeias (E.g. Ph.eur., Dab, Bp, Usp, Jp)
Driving License Of Classes: B
Advanced Knowledge In The Field Of Environment, Health And Safety

Languages

German

Native

English

Advanced

Education

Mar 2004 - Jan 2010

HAW University of Applied Sciences Hamburg

Diploma Engineer (FH) · Process Engineering · Hamburg, Germany

Aug 1997 - Jan 2000

Beiersdorf AG

Chemical Laboratory Assistant · Hamburg, Germany

Certifications & licenses

QM-Auditor According To ISO 19011

Quality Manager According To ISO 9001

TÜV Certified Quality Management Officer

Statistics

Experience

Total positions 10

Experience in Healthcare 16 y

Avg length 2 y 1 m

Longest experience 5 y 10 m

Global Experience

Countries worked in 1 (Germany)

Primary country Germany

Expertise

Recent roles Freelancer / QM Consultant, Quality Engineer in Quality Operations / Validations, Quality Engineer in Quality Operations

Main industries Healthcare, Pharmaceutical, Manufacturing

Main business areas Quality Assurance, Project Management, Production

Qualifications

Highest degree Bachelor

Certifications earned 3

Profile

Created

July 2025

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Frequently asked questions

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

Where is Kai based?

Kai is based in Hamburg, Germany and can operate in on-site, hybrid, and remote work models.

What languages does Kai speak?

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

How many years of experience does Kai have?

Kai has at least 21 years of experience. During this time, Kai has worked in at least 9 different roles and for 10 different companies. The average length of individual experience is 2 years and 1 month. Note that Kai may not have shared all experience and actually has more experience.

What roles would Kai be best suited for?

Based on recent experience, Kai would be well-suited for roles such as: Freelancer / QM Consultant, Quality Engineer in Quality Operations / Validations, Quality Engineer in Quality Operations.

What is Kai's latest experience?

Kai's most recent position is Freelancer / QM Consultant at ValiQuali.de.

What companies has Kai worked for in recent years?

In recent years, Kai has worked for ValiQuali.de.

Which industries is Kai most experienced in?

Kai is most experienced in industries like Healthcare, Manufacturing, and Pharmaceutical. Kai also has some experience in Biotechnology and Energy.

Which business areas is Kai most experienced in?

Kai is most experienced in business areas like Quality Assurance, Project Management, and Production. Kai also has some experience in Product Development, Research and Development, and Operations.

Which industries has Kai worked in recently?

Kai has recently worked in industries like Healthcare.

Which business areas has Kai worked in recently?

Kai has recently worked in business areas like Project Management and Quality Assurance.

What is Kai's education?

Kai holds a Bachelor in Process Engineering from HAW University of Applied Sciences Hamburg.

Does Kai have any certificates?

Kai has 3 certificates. These include: QM-Auditor According To ISO 19011, Quality Manager According To ISO 9001, and TÜV Certified Quality Management Officer.