Oshrit Elmakias
QA Engineer at Rapid Medical- Claim this Profile
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Experience
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Rapid Medical
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United States
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Medical Device
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1 - 100 Employee
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QA Engineer
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Aug 2022 - Present
•Manage DCOs and ECOs. •Perform incoming inspections. •Manage NCR and CAPA processes. •Review and approve DHRs for batch release, labels, and route cards. •Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP. •Write and update QA procedures to ensure compliance with quality standards and regulatory requirements • Employees QA training management, including LMS system implementation • Supporting and implementing LMS (Learning management system): including user support, building trainings in the system for the whole company employees, effectiveness check control and overall responsibility for regulatory demands related to employee’s qualification. • Arena administrator responsibilities. • Supporting PLM (Product lifecycle management) system: including problem solving, user support, control on user usage of the system, document control • Perform route cards validations Show less
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Configuration Management
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Apr 2020 - Aug 2022
Head of the configuration management team at production headquarters, responsibility for managing the configuration control of products including the establishment of the configuration management infrastructure. Planning and managing the product life cycle, establishing the product trees and being responsible for their health. Execution of change instructions (ECO), and their distribution. Working interfaces with departments: procurement, marketing, planners and project engineers. Configuration management representation and production engineering information with the customer. Implementation of work processes and solutions in the PLM (Product Lifecycle Management system). Collection and analysis of requirements and improvement of cross-organizational work processes in the PLM information system, user support, writing work procedures and methods, including mentoring for employees. Show less
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Supplier Quality Inspector
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Oct 2018 - Apr 2020
Managing all the quality aspects of outsourcing suppliers, defining work processes and implementing them with suppliers, approving suppliers and material specifications, accompanying suppliers in quality aspects and technological aspects, handling nonconformities, monitoring performance and documenting laboratory tests, calibrations, external laboratories, shelf life and product testing, implementation Corrective activities.
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Israeli Military Intelligence - Unit 8200
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Israel
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Armed Forces
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700 & Above Employee
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Operational techno liaison
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Jan 2012 - Jan 2014
Operational techno liaison with high security classification, acquisition of technical knowledge regarding intelligence systems, development of understanding and technical and professional thinking. Providing an initial solution to classified technical problems and full responsibility for the quality of troubleshooting. The job required manpower operation, dealing with complex stressful situations. Advanced transmission systems, basic familiarity with RF components and absorption routes. Outstanding Commander of Unit 8200 - Northern Space Show less
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Education
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Kinneret Academic College
Bachelor of Applied Science - BASc, Quality and reliability engineer -
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