Software Quality Assurance Specialist

5 days ago


Athlone, County Westmeath, Ireland HERO Recruitment Full time
Job Description

This is a unique opportunity to join a global medical device organization as their software validation site lead. As a software quality assurance specialist, you will play a critical role in ensuring compliance with FDA and ISO 13485 regulations.

Key Responsibilities:

  • Lead software validation activities, including development and maintenance of validation plans, protocols, and documentation.
  • Collaborate with cross-functional teams to ensure new software applications meet regulatory standards.
  • Develop and maintain risk assessments, test scripts, and traceability matrices.

Requirements:

  • Bachelor's degree in Engineering, Computer Science, or a related field.
  • Five years of experience working in a regulated environment, specifically in medical devices.
  • Strong understanding of software validation principles and regulatory requirements.


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