Kai (Matthias) Jeske
Freelancer / QM Consultant in the field of medical technology and pharmacy
Experience
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
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 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
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
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, 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
Education
HAW University of Applied Sciences Hamburg
Dipl.-Ing. (FH) · Process Engineering · Hamburg, Germany
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
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