QA Validation Engineer

Posted 03 April 2024
LocationCounty Leitrim
Job type Permanent
Discipline EngineeringQuality & Laboratory
Reference10764-M
Contact NameAshley Egan

Job description

What you need to know

Our client, an Irish-based medical device company who are currently seeking an experienced QA Validation Engineer to join their organisation.

This is a full-time position where you will be required to be on site in Co Leitrim.

You will manage, inspect, calibrate, test and modify the instrumentation, equipment, mechanics, and systems that manufacture various products. You will also investigate the causes of equipment failures and anomalies.

 

Your new job

Key duties & Responsibilities:

  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.

  • 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 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

  • Management of QA/Technical/Associate/Engineers (Validation), as applicable, Senior QA Engineer (Validation)

What are we looking for?

  • Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.

  • Ideally 2-3 years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.

  • An Associate position may exist where there is limited experience.

  • A Senior position may exist for a minimum of 6 years’ experience.

 Apply for this job now by sending in a Word version of your CV or get in touch with Ashley at ashley@matrixrecruitment.ieor alternatively by phone at 087 113 7061.

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