Мы эффективно работаем.
Мы завоевываем доверие.
Мы Smith & Nephew.
- Lead all QA activities for CEE Commercial organization.
- Lead the implementation of Smith + Nephew Global Management System in the CEE cluster and ensure compliance to ISO 13485 and MDR (where applicable) requirements.
- Maintain QMS documentation to current standards & needs.
- Create awareness on quality system requirements within the organization. Work within cross-functional teams to ensure compliance and bring improvements in the complete processes within the Warehouse and Distribution channel.
- Audit both internal and 3rd party to make sure they perform to ISO standards, local regulations and S&N requirements.
- Proactively monitor trends of quality data, to identify opportunities for system, process and product improvements
- Provide leadership and strategic direction to optimize the processes of quality management and ensure compliance with regulatory requirements Represent the company during external audit/inspection, creates and maintains strong relationships with internal and external stakeholders, notified bodies.
- A bachelor's degree in engineering or scientific is required
- Minimum 5 years’ experience in quality management
- Good understanding of the Russia medical device regulatory systems and GDP requirements
- Good understanding of the medical device industry and its Code of Conduct
- Knowledge of policies and procedures required for certification to ISO 13485 and/or GDPs
- Advanced Microsoft office proficiency.
- Excellent knowledge and experience in the implementation of the relevant recall procedure for medical devices and post market surveillance
- Proficient in Russian and English, both verbal and written
- Demonstrated ability to consistently achieve regulatory and quality requirements
- Successful track record in internal audit, quality or analysis and development of work processes
- Successful record of managing quality in a multi-national organization with diverse cultures
- Skilled in strategic planning and setting annual goals
- Systematic, thorough, accurate and disciplined
- Full compliance with labour law
- Competitive salary
- Bonus after year results
Компенсация мобильной связи
Обеспечение здоровья и благополучия сотрудников
Quality Manager CEEВ архиве с 18 ноября 2020
з/п не указана