Staff Market Quality Specialist

Дата размещения вакансии: 22.11.2020
Работодатель: Brunel Russia
Уровень зарплаты:
з/п не указана
Город:
Москва
Требуемый опыт работы:
не требуется

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, Japan JPAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA
  • 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 (e.g. Mexico Sanitary responsible)
  • 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, FDA 21 CFR 820, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001, ISO 14971
  • Business fluency in English and Russian is a must
  • Proven analytical/quantitative skills
  • Project management skills, with the ability to drive change and influence decision making through multiple levels

We offer:

  • Working with international company with multinational culture
  • Professional and friendly team
  • International projects
  • Competitive salary and social package
  • Growth opportunities