Senior Quality Engineer

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Senior Quality Engineer

GxPeople are partnered with 2 x Medical Device companies who are both looking for Quality Engineers.

 

1 role based in Limerick

1 role based in Galway

 

Senior Quality Engineer

 

Main Responsibilities:

  • Batch review and product release of sterile and non-sterile product
  • Ensure compliance with the Quality management systems in place (ISO 13485/15378/14001/ FDA 21CFR Part 820) and other relevant standards.
  • NC's investigations (both Internal and External).
  • CAPA management
  • Documentation of Vendor notified changes
  • Liaise with NPI department in relation to component set up and validation activities and with vendors and customers in relation to Quality related matters.
  • Management of Environmental results including data trending and reporting
  • Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.

 

 

Desired qualifications:

  • A Degree in Science, Engineering or a relevant discipline.
  • Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
  • Proven knowledge and experience with minimum 3 of working within the Medical Device Industry
  • Strong knowledge of ISO13485, ISO14971 regulations

 

Must have right to work in ROI!!

 


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