Kai (Matthias) Jeske
Freelancer / QM Consultant
Experience
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
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
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
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
Sales and Project Engineer Biogas Production
HeGo Biotec GmbH
- Process engineering; desulfurization of biogas
- Sale of desulfurization substances
Pharmaceutical Process Engineer in R&D
Biomet Deutschland GmbH
- Process engineering; process development for a combination product
- Process validation and qualification of equipment
Freelancer Quality Assurance
K.-W. Pfannenschmidt GmbH
Chemical Laboratory Assistant in Quality Control
Dental Material Gesellschaft mbH
Community Service in the Kitchen of a Hospital
Elbe Kliniken Stade-Buxtehude
Chemical Laboratory Assistant in Quality Control
Beiersdorf AG, Division Medical
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 (15.5 years), Pharmaceutical (2 years), Manufacturing (2 years), Biotechnology (0.5 years), and Energy (0.5 years).
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 (19.5 years), Project Management (11.5 years), Production (6 years), Product Development (2.5 years), Research and Development (2.5 years), and Operations (1 year).
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
Education
HAW University of Applied Sciences Hamburg
Diploma Engineer (FH) · Process Engineering · Hamburg, Germany
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
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