Quality Manager # 9600

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

REQUIREMENTS

• +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

Will be a Plus:

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