Inga Shengof

Project management: design control process for new product, change management, developing and executing V&V plan, introduction and approval for clinical trial in the US.

Establishing, implementing and maintaining ISO 13485 certified quality management system in a startup company in the field of robotic surgery. Main responsibilities: suppliers quality management, ‘Design to Manufacturing’ transfer activities including; process validation (including software validation), process FMEA, standards requirements implementation, change control. Design quality control activities for new products development.

Deviation and CAPA management, manufacturing investigations, sterilization process and product testing SME, CEA oversight, process validation planning, execution and approval, standards implementation, risk analysis and FMEA, conducting internal audits to QMS and production. Good knowledge and experiance with ISO 13485, MDSAP, FDA regulations.

Validation Engineer at BTG (through Incede Group- Medical and Pharmaceutical Validation)- writing and executing validation for pharmaceutical processes, equipment, utilities and clean rooms, deviations investigation, maintenance plan development etc.

- ALS research - Galectin 1 in Fibrosarcoma development

Final Project at Dr. Rachel Lichtenstein laboratory at the department of Biotechnology Engineering (2014-2015). Exploring the recapitulation of IgG antibodies in the cervical lymph nodes of mSOD1 mice. During the project and my work as research assistent I acquired knowledge and experience with documentary research work with animals, ongoing care and conducting experiments with laboratory mice, FACS analysis, image processing with confocal microscopy, cell growth and treatment and genetic engineering.