Position: Senior Quality Manager #9600
Company: Lohika
Category: Other
Experience required: 1y
English level: upper
Published: 2021-04-01T00:00:00+03:00

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