Senior QA / PMS Specialist
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
