Senior Quality Specialist (QMS)

Вакансия № 9094915 от компании Align Technology Inc на Электронной Службе Занятости Населения Москвы.

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☑ Основной блок:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 9094915 добавлено в базу данных: Среда, 12 февраля 2025 года.

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

☑ Статистика предложения работы № 9094915:

Прочитано соискателями - 332 раз(а);
Отправлено откликов - 0 раз(а);

☑ Репутация компании "Align Technology Inc":

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☑ Подробности о вакантном месте:

Senior Quality Specialist leads and directs the execution of the Quality Management System at Align Moscow R&D site to ensure compliance with regulatory requirements along with Align business strategy; serves as the site Quality Leader providing oversight, training and mentoring to the organization in quality matters, supports Software development, SQA and IT teams. He/She serves as the Site Quality Management Representative, leads and participates in Align-wide quality projects and initiatives.

The Senior Quality Specialist maintains all quality related policies and procedures on an ongoing basis to ensure regulatory compliance and to adhere to highest quality standards. He/she reviews the adequacy and effectiveness of the Quality System procedures by doing the following:

Manages the Quality Management System (QMS) for Align Moscow site and controls QMS documentation
Maintains all documentation of quality audits, inspection records, countermeasures, and other related documentation
Monitors regulatory compliance and adequacy of SDLC design control procedures to ensure continuous improvement in quality management process
Applies modern quality tools for analyzing data to evaluate current processes and recommended adequate changes in processes
Manages the management review process

Job Requirements:

Higher Education Degree in Engineering, Computer Science or equivalent.
Strong knowledge base of quality audit processes and expectations
Working knowledge of ISO 9001 standard; ISO 13485 and/or ISO 62304 is a plus
Minimum of 3 years of related experience and/or training, preferably in Software/IT or medical device industry.
Ability to lead cross-functional matrix teams.
Proven track record spanning Software Development and Quality Engineering; medical device industry experience is a plus.
Strong working knowledge of Risk Management practices.
Strong problem solving skills.
Fluent English.
Proven success in driving cultural change and being a change agent.

We offer:

Employment according to the Labor law
Competitive salary and annual bonuses
Professional development and career growth, trainings, conferences, English and Spainish classes
Voluntary Medical Insurance for all employees and their children (with dental treatment)
Lunch allowance
31 vacation days, paid days-off.
Democratic and open culture
Gym in the office
Corporate events for employees and their children
Flexible working hours (usually 11:00 до 19:45)