Our client is a world-leading medical device company based in the West of Ireland. With a market presence in over 90 countries, across 3 continents, this expanding company are seeking skilled Validation/Compliance Quality Engineers to join their team.

The Role

Reporting to the Senior Quality Engineer, this compliance Quality Engineer, working with Engineering, Manufacturing, Supply Chain and Product Development is responsible for:

• Completing equipment and process validation through FAT, SAT, IQ, OQ, PQ protocol development, implementation and review, and approval of the subsequent report
• Supporting quality improvement and ISO 13485 and FDA compliance activities as needed
• Ensuring QSR internal and external readiness
• Reviewing and approving statistical analysis per Quality System requirements
• FMEA and Risk Management support through cross-functional input
• Providing assistance on CAPA investigation, as required

The Person

In order to undertake their duties effectively, the Quality Engineer must have:

• A degree in Science or Engineering and have a Quality Engineering qualification or equivalent
• 2 - 3 years' experience in Medical Device Industry
• Technical knowledge of Quality Compliance with cross-functional experience

The Benefits

• Salary (DOE)
• Family healthcare
• Contract completion bonus
• 23 days annual leave

To discover more about this opportunity, apply now or contact Aidan Toner at HRM on 091 782110 for a confidential discussion.