Work Flexibility: HybridWhat you will do:Develop and maintain the effectiveness of local QMS in accordance with the company objectives and applicable requirementsMaintain, develop and/or revise QMS process documentation aligned with ISO 13485:2016 standard to incorporate appropriate regulatory and EEMEA requirementsEnsure that EEMEA procedure and document changes are reviewed and implemented where appropriate into the local QMSExecute QA activities in line with defined procedures and processes, such as - internal audit process, supplier management, document control, risk management, NC-CAPA and othersCooperate with RA specialists for timely organization and execution of manufacturing site inspections in accordance with applicable local regulations based on annual registration plan and business prioritiesExecute PMS activities, such as Product complaints, Product Field Actions and Commercial holds, in line with defined procedures and legal regulationsWhat you need:Required:2+ years’ experience in a related QA positionPrior experience in medical device or pharmaceutical companyPreferred:Bachelor’ degree in Engineering, Medical Device Technology or Scientific FieldRussian - native speaker, English – upper intermediateQualified as QMS Internal Auditor (ISO 13485 medical devices preferred)Project management and time management skills, coordination and execution of projectsTravel Percentage: 10%
