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BrightPath Recruitment

QA Engineer-Validation

BrightPath Recruitment

  • Longford / Leitrim / Sligo
  • Negotiable
  • Permanent full-time
  • Updated 17/10/2017
  • Elaine
this job is expired
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Description

QA Software Validation Engineer

 

Brightpath Recruitment Engineering & Life Sciences is currently seeking a QA Software Validation Engineer for our client a medical devices company, in Leitrim. 

This is a permanent position offering a competitive benefits package and an opportunity to advance your career within the medical devices industry.

Working across different departments the QA  Engineer is responsible for ensuring that product introductions and change controls are effectively managed in accordance with the requirements of ISO 13485 and MEDDEV 93/42/EEC.

 Responsibilities:

  • 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

 Qualifications

  • Third level Qualification in Engineering or Science
  • Computer Systems Validation expeirence
  • 2-3 years previous experience as Quality/Validation Engineer in Medical Device / Pharma environment.

Ref: QVE0517C
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BrightPath Recruitment

BrightPath Recruitment

 

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