Moscow, RUS
23 days ago
Senior Quality Assurance / Post-market Surveillance Specialist
**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 Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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