Sofia Epshtein Elbrus
Expertise Manager and Global Conformity Assessment Specialist MDSAP, ISO 13485, ISO 9001
- Role
- Expertise Manager - Technical Team Global Conformity Assessment Specialist at TÜV SÜD
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Sofia Epshtein Elbrus
Proactive and visionary manager with proven experience in the international product compliance and quality field. I specialize in driving improvement and establishing best practices in Product Compliance, Quality Assurance and QMS in highly regulated industries (Medical, O&G).Specialties: Management, People development, QMS (ISO 13485, ISO 9001, API Q1, ISO 17025, ISO 17021), MDSAP, API, Quality Assurance, QC, Continuous Improvement, CAPA, Quality Engineering, Six Sigma, Regulatory requirements (Regulation (EU) 2017/745, 21 CFR), Compliance testing, Certification and surveillance inspections, CE, FDA, HSSE
Experience
Expertise Manager - Technical Team Global Conformity Assessment Specialist
Jan 2024 — Present
Education
The Open University of Israel
B.SC
Tel Aviv University
Faculty of Physics
Skills
- Telecommunications
- Product Development
- Embedded Systems
- Wimax
- Rf
- Quality Control
- Engineering
- Pcb Design
- Quality Management
- Wireless
- Business Development
- Cross-Functional Team Leadership
- Alarms
- R&D
- Etl
- Compliance Testing
- Testing
- Fcc
- Ul
- Wifi
- Electrical Engineering
- Systems Engineering
- Sales
- Product Management
- Project Management
- Electronics
- Erp
- Sales Process
- Alarm Systems
- International Sales
- Lte
- Wireless Testing
- Marketing Research
- Cellular Communications
- Quality Assurance
- Design for Manufacturing
- Iso 13485
- Project Coordination
- Medical Devices
- Manufacturing
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