Sofia Epshtein Elbrus

Experience

• 

  Israel Defense Forces

  Jan 2000 - Jan 2002

  First Lieutenant
• 

  Hermon Labs

  Mar 2003 - Jan 2013

  (part-time employment, Jan 2011 - Nov 2013 as a contractor)Product quality auditor authorized by Intertek ETL, TUV Rheinland and MET laboratories as an NRTL factory inspector for the following fields:- ALI/ETL Inspections- FAA Quality Program Audits - Gas & Oil Inspections- Sanitation Inspections- Sample Product Inspections * Market research and business development of testing services and certification solutions for international markets for medical applications, alarm and military systems and wide variety of wireless technologies.* Full project management for major accounts, beginning with price proposal and up to final certification.* Sales* Monitoring and optimization of the laboratory work processes and ERP system per the requirements of ISO 17025 * Product Safety department project handling* Laboratory point of contact towards customers and external certification bodies. * Coordinating projects A-to-Z flow within the company* Optimization of the laboratory ERP system

  • Quality auditor

    Jan 2006 - Jan 2013

  • Sales & Marketing, Account manager

    Jan 2007 - Jan 2011

  • Project Coordinator

    Mar 2003 - Jan 2007
• 

  ELV Quality and Regulatory Solutions Ltd.

  Jan 2011 - Jan 2014

  Founder

  After years of working at the very core of international compliance industry and gaining wide and valuable knowledge in the field of regulation of Medical Devices and Information Technologies, ELV team is building the optimal path for our clients to establish and maintain a mature QMS and meet Product Compliance requirements.Using our team professional experience we provide an efficient and balanced certification program that perfectly suits our clients needs.After the program is approved our clients receive full guidance and support until the desirable certificates and registrations are received. Pokaż mniej

• 

  UPG

  Jan 2014 - Mar 2016

  Quality Manager

  Quality Manager ASQ CQE and active member of the American Society for Quality

• 

  BSI

  Mar 2016 - Mar 2017

  Client Manager / Auditor - Healthcare

  Audit per the requirements of MDD 93/42/EEC, CMDR, ISO 13485 (2003 and 2016) and ISO 9001 (2008 and 2015).

• 

  CDI Energy Products

  Mar 2017 - Jan 2021

  Quality Manager

  After the merger of the two sister companies serve as the Quality Manager for both CDI and EGC brands. ISO 9001:2015 and API Q1 certified QMS.March 2017-August 2018 - Quality Manager of EGC Critical Components.Participated in preparation of the company to ISO 13485 certification (obtained shortly after my departure).

• 

  BEPC Inc. - Business Excellence Professional Consulting

  Jan 2021 - Jan 2022

  Consulting Lead Auditor for Johnson & Johnson Regulatory Compliance

  Perform risk based Supplier and Strategic Partners Quality Audits on behalf of Johnson & Johnson Regulatory Compliance EMSA.

• 

  TÜV SÜD

  Jan 2022 - now

  Audit Department Manager, Non-Active Medical Devices. Global Conformity Assessment Procedure Specialist - MDSAP, (EN) ISO 13485, ISO 9001

  • Expertise Manager - Technical Team; Global Conformity Assessment Specialist

    Jan 2024 - now

  • Audit Department Manager and Global Conformity Assessment Procedure Specialist

    Jan 2022 - Jan 2024