QA Validation Engineer
Leitrim

Leitrim
Full time
GxP are delighted to be working with a Medical Device team in Co Leitrim who are now looking to add a QA Validation Engineer to the team, As the QA Validation Engineer you will be involved in:
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845. 
  • Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
  • Completion of Validation Programme – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures
  • Review and Release of batch paperwork for Product release
  • Requirement to work on numerous projects at one time. Required to be flexible to complete all projects.

Ideally candidates will have a minimum of 2 years experience in a manufacturing setting.