Quality Manager CEE

Вакансия № 16556800 от компании Smith & Nephew (Смит энд Нефью) на Электронной Службе Занятости Населения Москвы.

☑ Основной блок:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

Это объявление № 16556800 добавлено в базу данных: Среда, 5 марта 2025 года.

Дата его обновления на этом интернет-ресурсе: Понедельник, 17 марта 2025 года.

Прочитано соискателями - 139 раз(а);
Отправлено откликов - 0 раз(а);

Responsibilities:

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.

Requirements:

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