This leading medical device organisation has been a long time investor here in Ireland with operations in Ireland since the 1960's. Employing in the region of 70,000 employees and revenues north of 16 billion per annum, they remain one of the largest medical devices organisations globally. Since its introduction to Ireland, this innovator has proceeded to continuously invest in this country including investments in additional manufacturing and research sites across Ireland. One of the organisations primary plants based in Limerick is currently undergoing significant investment and change and has transformed its operations in Ireland through strong leadership, continuous innovation and demonstrating the importance of this site to the organisation's global operations. At present, a requirement exists for a Senior Quality Engineer - Design Assurance to join it's expanding operation in Limerick.
As a Senior Quality Engineer - Design Assurance, you will represent the Quality Function on Project Teams for both new product development and existing products.
In addition, you will be responsible for:
- Design Assurance Quality Engineer on project core teams for design change projects
- Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction
- Write project quality plan
- Lead risk management activities within the project
- Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements
- Assist / conduct Failure investigations and problem-solving sessions
- Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports
- Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing
- Ensure process validation activities are completed appropriately and make the link with product design whenever needed
- Conduct quality functional reviews and DHF compliance reviews
- Ensure compliance across projects for design control, risk management and change control processes
You will have a minimum of 5 years' experience in a similar role. A third level qualification, ideally in engineering or science is required.
To discover more about this opportunity, apply now or contact Anna Carey at HRM on +353 21 4511190 for a confidential discussion.