Kai (Matthias) Jeske

Freelancer / QM Consultant in the field of medical technology and pharmacy

Hamburg, Germany

Experience

Dec 2020 - Present
4 years 8 months

Freelancer / QM Consultant in the field of medical technology and pharmacy

ValiQuali.de

For example:

  • Stryker Trauma GmbH**

  • Qualification of production facilities and process validations of a new production line for the manufacture of implants incl. URS, IQ, OQ and PQ.

  • Abiomed Europe GmbH**

  • 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 int. 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

(Employee assignment, Kelly Services)

  • 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, Devision Medical

Summary

I have built a solid career in quality management and process engineering within the medical technology and pharmacy sectors. I bring hands-on experience in production facility qualification, process validation, and data integrity compliance, along with a strong background in risk management and CAPA. My work spans from technical validations at Johnson & Johnson Medical to improvements in cleaning and sterilization processes at Olympus and Waldemar Link.

My expertise has grown through roles in both industry and consultancy, underlined by a technical degree in Process Engineering and several TÜV certifications. I excel in delivering reliable and effective results, ensuring high standards and regulatory compliance in every environment.

Languages

German
Native
English
Advanced

Education

Mar 2004 - Jan 2010

HAW University of Applied Sciences Hamburg

Dipl.-Ing. (FH) · Process Engineering · Hamburg, Germany

Aug 1997 - Jan 2000

Beiersdorf AG

Chemical Laboratory Assistant · Hamburg, Germany

Certifications & licenses

Driving license of classes B

QM-Auditor according to ISO 19011

TÜV

Quality Manager according to ISO 9001

TÜV

TÜV certified Quality Management Officer

TÜV