Kai Jeske - Freelancer / QM Consultant

Hamburg, Germany

Experience

Dec 2020 - Present

5 years 1 month

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

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