What you will do:

Develop and maintain the effectiveness of local QMS in accordance with the company objectives and applicable requirements

Maintain, develop and/or revise QMS process documentation aligned with ISO 13485:2016 standard to incorporate appropriate regulatory and EEMEA requirements

Ensure that EEMEA procedure and document changes are reviewed and implemented where appropriate into the local QMS

Execute QA activities in line with defined procedures and processes, such as - internal audit process, supplier management, document control, risk management, NC-CAPA and others

Cooperate 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 priorities

Execute PMS activities, such as Product complaints, Product Field Actions and Commercial holds, in line with defined procedures and legal regulations

What you need:

Required:

2+ years’ experience in a related QA position

Prior experience in medical device or pharmaceutical company

Preferred:

Bachelor’ degree in Engineering, Medical Device Technology or Scientific Field

Russian -  native speaker, English – upper intermediate

Qualified as QMS Internal Auditor (ISO 13485 medical devices preferred)

Project management and time management skills, coordination and execution of projects