от компании (организации): MINDRAY MEDICAL RUSSIA , LTD в городе (населённом пункте): Москва, Россия
в отрасли экономики "Продажи, обслуживание клиентов" → "ГСМ, нефть, бензин"
с заработной платой: по договоренности
Вакансия № 28674724 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 29 октября 2024 года.
Дата обновления вакансии № 28674724 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 11 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 28674724 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Senior Quality Engineer
Mindray Technologies
Senior Quality Engineer is responsible for quality management system maintenance of Mindray reagent factory, manufacturing process quality assurance of the reagent product, inspection of the reagent product, and post-marketing quality management of the reagent product.
Job Duties
- Set up, maintain, and implement the quality system of the reagent factory, to be consistent with the ISO 13485 quality system and Russian medical device regulations, and to be compatible with the quality system of the Mindray Shenzhen.
- Plan and organize the internal audit, maintain the internal audit process, and ensure the effectiveness of the quality system.
- Organize external audits and ensure the effectiveness of the quality system certification.
- Maintain the management review process, plan the management review, report the operation of the quality system to the company's management, and drive the management to make quality improvement decisions.
- Maintain the document management process and daily document management, such as document review, control, and document issuance.
- Organize quality improvement, including but not limited to non-conformance problems identified through internal and external audits, and improvement items in management review decisions.
- Take charge of the admission and exit control of new product import activities and ensure that the requirements of the quality system are met.
- Review and sign for approval of special process verification and equipment and facilities verification.
- Review and control process, equipment, and environment changes.
- Organize the investigation and disposal of nonconformities and other quality events in the manufacturing process according to the quality system document requirements.
- Prepare and manage inspection laboratories, inspect raw materials, semi-finished products, finished products, and reserved samples of reagent, monitor the clean production environment, and detect process water and gas used in processes to ensure that clean production conditions are continuously met.
- Manage products release.
- Be responsible for customer complaint and product return/exchange information acceptance, preliminary investigation, task assignment, progress tracking, measure verification, and closed-end whole process management.
- Monitor, evaluate, and report adverse events.
Requirements
- A person shall have a higher professional (biochemistry, immunology, molecular biology, bioengineering, medicine, chemistry, and chemical engineering) education
- English (reading, writing, speaking) on intermediate and above level
- Experience in R&D, manufacturing or quality management of related medical devices and medicines for at least 3+ years
- Be dedicated, proactive, responsible, good at communication and team cooperation.
- To have a certain understanding of ISO13485 and related regulations.
Conditions
- Fix Salary
- Job Grade
- Additional Medical & Life Insurance
Откликнуться на эту вакансию: Senior Quality Engineer
Предыдущая вакансия:
Вакансия № 28674720 на должность Брошюровщик от компании Типография РОЛИКС в городе (населенном пункте) Москва