Software Quality Engineer with at least two years experience in a software quality assurance or CSV role within the medical device industry required for permanent role with market-leading medical devices client in Galway.

Responsibilities:

  • Lead Quality and Compliance activities in relation to Software projects
  • Support, guide, and monitor projects, to ensure that approved software development standards, processes, and procedures are adhered to, while also guiding the adoption of industry best-practices
  • Ensure that processes, SOPs and forms for computer systems control and validation 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
  • Author computer system validation documentation; test scripts, protocols, reports
  • Pre and post execution approval for all validation test scripts
  • Review and approval of deviations arising from computer system validation activities. Provide input into addressing deviations and approval of deviation outcome

Requirements:

  • B.Sc. Degree in Computer Science or Quality Assurance
  • At least two years must be within a quality assurance or related role 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 Parts ll & 820
  • Familiarity with GAMP5 Guideline for ‘Risk Based approach to GxP Compliant Computerised systems
  • Ability to work within a team environment to achieve agreed company goals
  • Ability to communicate effectively with all levels of the company
  • Ability to meet deadlines and follow through on assigned deliverables
  • Attention to detail
  • Proficiency in use of desktop software applications such as MS Office

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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