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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
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