Job Detail

Location Galway
Salary Negotiable
Role Type Permanent
Contact Karl Lippett

Software Quality Engineer

Software Quality Engineer (CSV)

Lead Quality, Compliance and Computer Software Validation (CSV) activities in relation to software used in business systems, laboratory & manufacturing equipment, product development and products.


  • Continue to meet the requirements of relevant regulations and are fit for purpose.
  • Collaborate with project teams to determine the validation strategy and plan for execution.
  • Quality reviewer on CSV and system supporting documentation.
  • Lead Quality and Compliance activities in relation to Software projects.
  • Author computer system validation documentation; test scripts, protocols, reports.
  • Pre and post execution approval for all validation test scripts.


  • Computer Software Validation within the medical device industry
  • Experience of implementation and validation software business systems is desired.
  • Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR
  • Familiarity with GAMP5 Guideline for 'Risk Based approach to GxP Compliant Computerised systems.

For further information on this role please contact Karl Lippett on 0861070950 /
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Software Quality Engineer

Karl Lippett

Role Type Permanent
Contact Karl Lippett
mobile +353 86 107 09 50
linkedIn profile click here