Self-employed consult and trainer in the field of quality management for medical devices.
Special areas of expertise:
Quality Engineering activities for a new heart-lung-machine
Mehrtägiger vor-Ort Workshop mit Trainingsanteilen zur Optimierung der Prozessvalidierung beim Kunden. Umfangreiche Hands-On Beantwortung von Herausforderungen des Kunden. Ca. 10 Teilnehmer auf Kundenseite im Hybrid-Setting.
Development of business processes in the areas of design transfer, software validation and inhouse manufacturing of manufacturing equipment; employee trainings, CAPA-owner; Validation engineer (consultation, review and approval of equipment qualifications, process validations, test method validations, validation master plans and reports); SME for audits and inspections
Hands-on head of Quality Management and Regulatory Affairs departments; responsibilities included e.g.: Worldwide product registration (ex. US); process controls; process validation; CAPA; design controls; risk management; reporting and handling of field safety corrective actions and other reportable events; continuous improvement of the quality management system (21CFR820 & 13485:2016); supplier quality management incl. QAAs; primary contact for the Notified Body as well as other regulatory bodies worldwide; quality management responsible; Much hands-on work by myself due to small available team size.
Complete revision or new introduction of the processes for equipment qualification, process validation, process design, statistical techniques for process validation and design verification and repair & maintenance of equipment; professional leadership of functions involved in the mentioned processes, employee trainings, validation engineer (consultation, review and approval of equipment qualifications, process validations, test method validations, validation master plans and reports); SME for audits and inspections
Part-time trainer for ?Process Validation for Medical Devices? on behalf of the TÜV SÜD Akademie GmbH
Risk management for production processes, development and communication of verification and validation strategies for manufacturing processes, software and test methods; design of experiments and statistical analysis; control planning; equipment and facility qualification; quality management responsible for new product development; coordination of changes on serial products with international customers; continuous improvement of statistical techniques; employee trainings; SME for audits and inspections
Autonomous research in the state funded reseach project ?Forming limits and spring back behavior in micro sheet metal forming?
?Select aspects of private law concerning the delegation of process validation to a medical device supplier via a quality assurance agreement?
General Quality Management
Quality Auditor (TÜV)
Quality Responsible (TÜV)
Advanced Product Quality Planning
Production Part Approval Process
Project Management Basic Training
The Voice in Business
The Voice ? Expression of Personality
Optimizing the Personal Impact
US Business Culture Training
Psychological Counselor (TMI)
Medical Device Specific
Quality System Requirements and Industry Practice (AAMI)
Post Market Surveillance for Medical Devices
Safety Responsible for Medical Devices acc. German Law
Do Not Be Scared of Reportable Events
Process Validation for Medical Devices
Nitinol in Medical Devices
Adhesive Bonding Technology
Biological Safety of Medical Devices
Biological Safety Testing of Medical Devices
FDA Regulatory Education for Industry Annual Conference 2021
Lived in the United States for two years
Supported American and Irish customers regarding quality management topics for multiple years
Publications: on request
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