Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Karl Lippett
email it@hero.ie

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.

Responsibilities:

  • 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.

Qualifications:

  • 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 / it@hero.ie
 
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
 
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Software Quality Engineer

Karl Lippett

Role Type Permanent
Contact Karl Lippett
email it@hero.ie
mobile +353 86 107 09 50
linkedIn profile click here