Software Validation Engineer



Our client is seeking a highly skilled Software Quality/Validation Engineer with a strong background in the Med-device industry. As part of the team, you will play a crucial role in ensuring the quality and compliance of their software products.


  • The validation and operational management of computerized systems.
  • The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
  • Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
  • Maintaining the quality and compliance status of associated Procedures, and work instructions.
  • Presenting and communicating status, reporting metrics, identifying trends potential issues, and improvement initiatives, as applicable.

Qualifications and Experience

  • Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.
  • 2-3 years of working knowledge of software validation in the medical devices industry.
  • Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider the experience in pharmaceutical validations

Organization Collins McNicholas Recruitment & HR Services Group
Industry IT / Telecom / Software
Occupational Category Software Validation Engineer
Job Location Kilkenny,Ireland
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Intermediate
Experience 2 Years
Posted at 2024-07-09 5:37 pm
Expires on 2024-08-23