Our client is a global medical device organisation based in Co Westmeath and is actively hiring for a Quality Engineer for a contract role.

The Position

You will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems.

Responsibilities will include:

• Initiating and completing technical activities and cost savings as part of process improvements through the update of risk documentation, procedural updates, test methods, process/software validation etc., that have a significant impact to the business.
• Initiating, reviewing, and approving change controls.
• Performing, analysing and interpreting statistical data using an understanding of statistical tools and methods.
• 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.
• Ensuring compliance is maintained for Product Manufacturing, Packaging and Labelling.
• Performing internal and supplier audits.
• Supporting and participating in external regulatory body audits, e.g., ISO and FDA
• Creating and analysing data for Quality Metrics.
• 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.
• Actively contributing to the enhancement of compliance initiatives for areas of responsibility

The Person

• 2-3 years' experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments is preferable.
• 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.

The Benefits

• Competitive salary.
• 9-month contract.

To discover more about this opportunity please apply online or contact Olivia Roger at HRM on +353 1 6321802 for a confidential discussion.