Veit Maager
Quality Manager, Regulatory Affairs, Risik and Validation Mangement
Experience
Test Method Development and Validation Engineer
Gebr. Renggli AG
- Test method validation for destructive testing (peel-force testing) according to ASTM F88/F88M
Quality Management System Consultant
Medipack AG
- Update of quality management system
- Process validation
- Statistics and statistical analysis
- Regulatory requirements (regulatory affairs)
- Method validation and process for medical device packaging systems (sterile barrier systems)
Project Manager MDD→MDR Transition
Karl Storz Endoscopy Production GmbH
- Transfer technical documentation (DHF/DMR) from MDD to MDR compliance for endoscopy products (devices and single-use)
- Test method development and validation for destructive (peel-force testing) and non-destructive testing (tightness-testing on tubing set)
- Verification and validation of sealing seams within process development at the supplier
Qualification and Process Validation Engineer
Geistlich Pharma AG
- Qualification and process-validation of packaging line (Form-Fill-Seal) for temporary sterile products for medical devices
- Establish form-fill-seal packaging line for small implantable medical device Class I and II
- Plan packaging performance and stability simulations based on ISO 11607-1, ISO 11607-2
Packaging Development Engineer
Medela
- Establish and maintain packaging development process for medical devices
- Plan and coordinate design verification of packaging system performance and stability (ISO 11607-1, ISO 11607-2)
- Arrange and perform notifications of change to notified body for terminally sterile products
- Design control/change management including risk management evaluation
Global Packaging Project Manager
Zimmer Biomet
- Align packaging systems and accomplish full compliance with international standards and regulatory requirements (FDA 21 CFR Part 820, MDD)
- Design control/change management for change activities including risk management coordination
Interim Packaging Development Engineer
Zimmer Biomet
- Packaging development remediation and packaging system changes
- Packaging system performance verification and shelf life verification planning according to FDA 21 CFR Part 820 and MDD 93/42 EEC
Interim Qualification and Validation Manager
Medipack AG
- Customer packaging validation
- Process validation including risk management
- Sterilization validation (ISO 11135, ISO 11137)
- Medical packages (pouches and blister) for medical devices Class I – III
Consultant Qualification Customized Test Equipment
ROCHE Diagnostics International
- Development and production of diagnostic test equipment (blood-gas sensors, no medical device class)
Consultant Medical Quality Engineering
Memry
- Measurement technologies
- Process engineering
- Validation process
- Nitinol semi-finished products
Interim Quality Engineer
Medtronic Invatec
- Validation of processes and test methods
- Verifications
- Process engineering in cardiovascular therapies – catheter and Nitinol stent production (Medical Devices Class III)
Deputy Quality Assurance Manager and Validation Officer
Georg Fischer PipingSystems - Medical Division
- QM process development (qualification and validation, risk management, CAPA management)
- Equipment qualification and process validation in production of medical devices (Class I)
Interim Quality Manager
Remp/Nexus AG
- Renew QM system including risk management, audit process, CAPA process (no medical device class, only storage equipment/sample management systems)
Consultant – Quality Management
Maager Quality Management GmbH
- Consulting on all quality management issues
- Building and monitoring quality management systems (ISO 9001:2008, ISO 13485:2003/AC2007, ISO 13485:2016)
- Risk management
- Design/process qualification, verification and validation
Quality/Product Manager
Roth Décolletage AG / Roth Medical AG
- Reorient quality management system to align with medical device requirements (ISO 13485:2003)
- Integrate development, validation, and supplier quality management
- Train employees on quality issues
- Handle complaints
- Product management
Quality Assurance Manager, Validation Officer
Disetronic Medical Systems AG
- Validation Officer
- Co-project leader for quality in development projects
- Ensure compliance throughout the projects
- Coordinate all quality issues during projects
- Responsible for addressing supplier quality queries
- Plan and conduct supplier audits across Europe
- Supplier evaluation, monitoring and development
Head of Quality & Regulatory Affairs, Vice President
Vascotube GmbH
- Plan and handle all quality issues within the company
- Plan and conduct internal audits
- Plan all inspections
- Supervise all quality results
- Manage corrective and preventive actions
- Risk management
- Reporting
- Complaint handling
- Lead all validation activities
Certified Engineer, Quality Assurance Manager
G. Rau GmbH & Co. KG
- Quality planning and inspection planning (tube, wire, and double production)
- Inspection planning (NiTi alloy, tube, and wire medical devices)
- Defect analysis
- Measurement equipment management
- Approval of certifications (according to ISO 10204 3.1)
- Complaint handling (German, English)
- Reporting (German, English)
- Customer contact in the USA
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 (25 years), Manufacturing (10.5 years), and Pharmaceutical (4 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 (25 years), Project Management (7 years), Product Development (6 years), Production (2.5 years), and Research and Development (0.5 years).
Summary
- Success in building industrial quality management systems
- Certain to arrange and execute audits (internal and supplier)
- Knowledge in quality statistics and process development
- Skilled in using quality management systems and quality management tools
- Long experience in development of terminally sterile medical device packaging
- Intelligence in conversations and negotiations with customers
- Skilled in training employees in quality issues
- Experience in qualification of equipment and validation of processes
- Smart in usage of OFFICE-tools (WORD, EXCEL, OUTLOOK, POWERPOINT)
- Experience in packaging development of medical devices
- Experience in shape memory alloy NiTi, behavior, production and products
- Knowledge of ASTM-/ ASQ-standards for statistics and medical device material
- Dedicated and able to work under pressure, always interested in learning new technologies and using well known things
Skills
Specialized Knowledge In Law Fda 21cfr Part 820, 21cfr Part 11, As Well Cgmp-guidance Documents
Packaging Development For Medical Devices Class I, Ii And Iii For Temporary Sterile Devices Acc. Iso 11607-1/-2
Validation Of Processes And Qualification Of Equipment
Risk Management According To Iso 14971
Part-leadership Of Development-projects
Material Knowledge In Steel (Cold Rolling, Forging, Tube Drawing), Special Alloys (Niti-alloys, Cu-alloys)
Metallographic Knowledge
Specialized Knowledge In Non-destructive Testing And Destructive Testing
Control Of Inspection, Measuring And Test Equipment
Experience In Process Development
Experience In Equipment Qualification
Experience In Process Validation
Experience In Risk Management
Experience In Medical Device Regulations
Experience In Clean-room Area Production
Experience In Internal And Supplier Auditing
Sample Size Planning
Auditor (Eoq & Dgq-tga)
Quality Manager Dgq (Qm)
Quality Representative Dgq (Qb)
Quality Technician Dgq (Q Ii)
Office-tools: Word, Excel, Outlook, Powerpoint, Visio, Project
Caq-systems: Ibs, Quipsy, Babtec
Sap R3 User-knowledge
Languages
Education
Robert Bosch Vocational College, Technical School, Duisburg-Hamborn
State-certified Materials Technician, Certified Engineer (Materials) · Materials Engineering, Material technologies · Duisburg, Germany
Kaltwalzwerk R. Mendritzki GmbH & Co. KG
Vocational training as materials tester, materials inspector - physics · Materials tester, materials inspector - physics · Plettenberg, Germany
Certifications & licenses
Certified Engineer, Material Technologies
Materials Inspector
Certified Calibration Technician
Profile
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