Quality Assurance Manager

Вакансия № 18393709 от компании Сarl Zeiss на Электронной Службе Занятости Населения Москвы.

☑ Основной блок:

Опыт работы: 1–3 года.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Место работы (точный адрес): Россия, Москва, Курская, Серебряническая набережная, 29.

Это объявление № 18393709 добавлено в базу данных: Четверг, 6 февраля 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

Прочитано соискателями - 76 раз(а);
Отправлено откликов - 0 раз(а);

Main Purpose:

Responsible for Development and support of Quality System ensuring a process\products\services meets the established standards of quality including reliability, usability and performance required for the market.

Responsibilities:

Region of responsibility: Russia, Ukraine, Armenia, Belarus, Kazakhstan, Kyrgyzstan

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with corporate policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Leads audit and inspection preparation findings and liaises with auditing groups. Accompanies internal and external auditors\inspectors through all stages of the audits.
Drive the improvement process in Quality field.
To define, develop, revise internal program, working instructions, procedures etc. to assure compliance with global policy and local regulation.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations to assure compliance.
To prepare reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
To establish Complaints Handling process.
To perform Vigilance (Medical Device Reporting) process including data analysis, gathering information, reporting to the local Competent Authority.
To perform action in the region regarding FSCA (including reporting to the local Competent Authority).

Requirements:

Higher education, scientific background is a plus (Biology, Chemistry, Medical devices, Pharma).
Knowledge of ISO 13485, ISO 9001.
Experience in building Quality Management System, developing processes, procedures and complaints handling at least 3 year.
Practice in developing SOPs, processes, working instructions.
English - Upper-Intermediate (writing, speaking).
Excellent interpersonal, collaboration, networking and communication skills.
Leadership competencies.
Analytical skills, strong decision making, high motivation.

Conditions: