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QA/RA Engineer

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Tiberias, Northern District, Israel

מס׳ משרה # שם משרה QA/RA Engineer תחום מדעי החיים תחום משני אזור בארץ עמקים וטבריה תיאור משרה QA/RA Engineer A Global Medical Device company, developing and manufacturing medical device designed for neuro-interventions (located in Yokneam) is looking for a QA/RA Engineer (Full Time position).Scope & Responsibilities: oReview change orders for completeness and accuracy of internal and regulatory requirements.oSupport implementation of new QMS digital systems. oManage training program of the organization.oProvides support during internal/external audits and regulatory inspections.oSupport file submissions in different regions (US, EU, Canada, Israel, ASIA, Australia and more).oSupport design and development changes from a regulatory perspective.oMaintaining RA procedures.oMaintaining Product Shipment Authorization.Requirements:oRelevant academic degree, [Register to View] in engineering and/or life science is preferable.oAt least years of relevant previous experience with document management in a regulated industry - pharmaceutical or medical device industries, with direct document control experience.oExperience in supporting international registrations.oEnglish - high level (both written and spoken).oExcellent teamwork ability and communication skills.oKnowledge of the relevant global Medical Device regulations.oFull control of all office applications.