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QA Engineer (Software Validation)

Job Title: QA Engineer (Software Validation)
Contract Type: Permanent
Location: Leitrim
Industry:
REF: 90042
Job Published: 5 months ago

Job Description

Contact: Catriona Coogan
Email: catriona@hero.ie
Telephone: 0872197421

QA Engineer (Software Validation)
Our client, a medical device company in Leitrim are currently looking to recruit a QA Engineer (Software Validation) for their site.


Required Qualifications/Experience/Skills:
  • Degree in Quality or Technical with emphasis on Medical Device Industry
  • Computer Systems Validation experience
  • Ideally 2-3 yrs experience in medical device or pharma industry
Duties/ Accountabilities (incl. Deputation):
This involves but is not limited to:
  • Required knowledge of GAMP.
  • Completion of software risk assessments
  • Knowledge and understanding of reading/generating IUS (Intended use statements), URS (User Requirements specifications), FS (Functional Specifications).
  • Completion of Requirements Traceability Records.
  • Generating Software Master Validation Plans, Software IQ's, OQ's, and PQ's.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845, in regard to software applications.
  • Maintenance of the plant software master plan
For further information on this QA Engineer (Software Validation) role in Leitrim please contact Catriona Coogan on 0872197421 / catriona@hero.ie
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