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
(Employee assignment, Kelly Services)
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.
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