Quality Engineer Role
Join a leading medical device company in Oranmore, Galway, and contribute to the delivery of life-changing products. As a Quality Engineer, you will play a pivotal role in ensuring quality and compliance across our manufacturing processes.
About Us
Our client has developed a highly effective solution for chronic rhinitis patients, both long-term and newly diagnosed. This innovative product is transforming lives, and we're committed to excellence in every aspect of its production.
Main Responsibilities:
* Develop, implement, and maintain quality assurance procedures to control materials and finished goods.
* Collaborate with suppliers to ensure quality standards are met and maintained as a key member of the operations team.
* Create and execute product quality control plans, documents, and procedures.
* Contribute to risk analyses and Process Failure Mode Effect Analysis (pFMEAs), including supplier involvement.
* Implement and enhance quality principles, analyzing quality data to drive product/process improvement activities.
* Oversee manufacturing-related quality events according to GMP and internal procedures, including process defects, CAPA, and complaint investigations.
* Address non-conforming material issues and work with manufacturers/suppliers to implement corrective and preventive actions.
* Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
* Offer quality input into process validation activities.
Requirements:
* BE/BS Degree; a Post-graduate qualification in Quality Assurance is preferred but not mandatory.
* At least three years of Quality Engineering experience or a related role within the medical device industry.
* Proven experience working in a medical device manufacturing environment complying with Good Manufacturing Practices.