Job Information
Stryker Senior Quality Assurance / Post-market Surveillance Specialist in Moscow, Russia
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Group: RAQA
Division: EMEA
Location: Moscow
Position Summary
Develops and applies intermediate knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation.
Responsible for developing and maintaining the effectiveness of QMS in accordance with ISO 13485:2016 standard and the applicable regulatory requirements.
Responsible for handling post-market surveillance (PMS) activities, such as Product complaints, Product Field Actions and Commercial holds.
Key Activities & Accountabilities
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 logal regulations.
Education
Bachelor’ degree in Engineering, Medical Device Technology or Scientific Field preferable
Experience
2+ years’ experience in a related QA position
Prior experience in medical device company is desirable
Knowledge/Competencies
Strong IT skills, including Microsoft Office.
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
High attention to detail and process consciousness, proactive mindset
Versatility, flexibility and willingness to work with changing priorities
Strong communication and team working skills, ability to communicate effectively with the team and management
High ethical standards and integrity
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.