Senior Quality Manager

Неактивна


Технологии:
ism iso communication manager education qms sharepoint jira confluence solid risk cybersecurity
Английский: eng: Не важно

Purpose of the job:

Ensure that project processes are in compliance with Lohika ISM and regulation (ISO 13485 and IEC 62304)
Continuously improve project processes

MAIN TASKS AND RESPONSIBILITIES:

  • Guides personnel how to comply with rules and processes
  • Coordinates risk management activities
  • Communication with the client Quality Manager on regulation-related questions
  • Coordinate the review and management of documentation created according to the regulatory requirements

EDUCATION, SKILLS AND EXPERIENCE:

MUST HAVE:

  • +1 years of experience in a combination of compliance, QMS, risk management
  • Practice-based knowledge of frameworks such as ISO 9001, ISO 13485, or equivalent standards
  • Experience in using documentation and issue tracking tools (SharePoint, Jira, Confluence, etc.)
  • Solid understanding of a software development lifecycle

WOULD BE A PLUS:

  • Risk management experience according to ISO 14971:2019 standard
  • Cybersecurity risk management experience
  • Knowledge of performing privacy impact assessment-related activities
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