от компании (организации): Brunel Russia в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 21690404 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 26 сентября 2024 года.
Дата обновления вакансии № 21690404 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 10 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 21690404 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Quality Specialist (with medical devices experience)
Наш клиент, международная компания-разработчик технологий очистки, дезинфекции и стерилизации медицинских инструментов, приглашает в свою команду Staff Market Quality Specialist
Responsibilities:
- Establish local and regional relationships with regulatory affairs, commercial, and logistics team
- Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring)
- Implements and supports Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, non-conformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance
- Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations
- Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics
- May serve as in-country Quality representative aligned with local regulations or laws
- Participates and hosts internal and external audits. May serve as liaison between local health authority and the business
- Supports quality team for a comprehensive audit readiness program to ensure internal and external quality compliance
- Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs
- Maintains quality oversight of any local required establishment licenses, or QMS certifications
- Maintains local supplier/vendor selection, qualification, and audits
- Maintains process for kitting/repack/relabeling activities (if any)
- Maintains quality records and adherence to records retention policies and procedures
- Maintains quality oversight of field service processes/procedures
- Maintains quality training program with respect to quality system elements
- Establish corrective and preventive actions to mitigate potential or actual noncompliance risks
- Assesses product quality issues and escalates to upper management through established processes
- Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management
- Ensures timely and consistent escalation of events
- Responsible for communicating business related issues or opportunities to next management level
- Performs other duties assigned as needed
Requirements:
- BS / BS degree (science or engineering preferred) at minimum
- Training of medical device regulations to include ISO 13485 and 21 CFR 820 at minimum
- Six Sigma Process Excellence and/or Lean Excellence Green Belt trained (preferred)
- ISO 13485 lead auditor qualifications (preferred)
- Minimum of 5 years of experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field
- Demonstrated knowledge of regulatory standards and regulations
- Business fluency in English and Russian is a must
We offer:
- Working with international company with multinational culture
- Professional and friendly team
- International projects
- Competitive salary and social package
- Growth opportunities
Откликнуться на эту вакансию: Quality Specialist (with medical devices experience)
Предыдущая вакансия:
Вакансия № 21690395 на должность Директор Департамента розничных продаж / Руководитель канала агентских продаж от компании ООО Страховая Компания Гелиос в городе (населенном пункте) Москва