Quality Engineer

Our client, a multinational medical device manufacturing company based in Athlone, is hiring for an inital 12-month contract for the role of Quality Engineer. The role is offering a hybrid-based position. The position will be based at their manufacturing site as part of the Manufacturing Quality team

Purpose of Job:

Responsible for initiating and performing defined quality activities leading to new or improved processes or systems

Key Responsibilities:

• Initiating, reviewing, and approving change controls
• Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling.
• Developing a strategy and implementing appropriate sampling methods
• Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering.
• Performing Internal and Supplier Audits.
• Supporting and participating in external regulatory body audits, e.g., ISO and FDA
• Complying with all relevant training required and adhering to relevant associated documentation.
• Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
• Following strict adherence to the requirements of CGMP.

Experience Required:

• Degree level qualification in Quality, Science or Engineering is required
• Minimum Three (3) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferrable.
• Medical device change control implementation
• Strong computer skills (MS Excel, PowerPoint, Word etc.)
• Familiarity with statistical tools such as Pareto charts and trend charts.
• Familiarity with FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools.
• Experience with problem solving techniques
• Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates.
• Ability to work within a fast paced team environment

Whats in it for you?

• Global medical Device company
• Hybrid working model
• Career advancement opportunities
• Flexibility to work with different teams within other manufacturing units.

For further informaiton on this position please contact Gillian Nicholson at or call Gillian directly on 0