Experience

Neurolief

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Engineer

  • Feb 2023 - Present



Active Implants

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Engineer

  • Oct 2020 - Feb 2023



Omrix Biosurgery Israel

• Israel
• Biotechnology Research
• 200 - 300 Employee

• Senior Quality Engineer

  • Dec 2016 - Oct 2020

  • SME for modular application device for a family of products, including overall product lifecycle (production processes, sterilization, sub-contractors and assembly). Supporting regulatory audits.• Maintaining an effective quality system for different regulatory bodies (FDA, EU, Canada, Australia, J&J franchise procedures, etc.) in compliance with GMP, ISO13485.• Leading change controls and device related projects, including design changes, product development, product release, preparation and approval of technical documentation, support TMV process.• Handling customer complaints, nonconformances and CAPAs, including root cause investigation, risk assessment and implementation of corrective and preventive actions.• Generation of annual product reviews, management review presentations, support regulatory submissions, technical file updates and DHF maintenance.• Collaborating with subcontractors: manufacturers, sterilization suppliers, external laboratories. Cooperating with various departments and functions in the company, locally and abroad, such as regulatory affairs, R&D, supply chain, supplier quality and working closely with J&J affiliates. Show less

• Quality System Analyst

  • Sep 2012 - Dec 2017

  • Leading change controls and document control process improvements, writing procedures and training company employees on quality systems • Define and implement new quality systems for GMP documentation and change control (ECO) processes.• Characterization of the different work processes for the different departments, supporting immediate and long-term changes to support the day to day activity.



Isracard

• Knowledge Manager and Customer Service Supervisor

  • Sep 2009 - Sep 2012

  • Fully knowledge of internal systems, working on SharePoint and CRM. • Technical writing and training employees on systems usage. • Working as part of a team as customer service supervisor and working independently as knowledge manager. • Providing internal and external services to the company and its clients. • Fully knowledge of internal systems, working on SharePoint and CRM. • Technical writing and training employees on systems usage. • Working as part of a team as customer service supervisor and working independently as knowledge manager. • Providing internal and external services to the company and its clients.