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Job Description
Job Title: Quality Engineer
Location: Oranmore, Galway
Summary: As a Quality Engineer, you will join the Operations team and play a pivotal role in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of medical devices that change lives.
Responsibilities:
- Develop, implement, and maintain quality assurance procedures and methods for control of materials and finished goods.
- Work as a key member of the operations team and with suppliers to ensure quality standards are met and maintained.
- Develop and execute product quality control plans, documents, and procedures.
- Provide input to risk analyses and Process Failure Mode Effect Analysis (pFMEAs) including with suppliers.
- Implement and enhance quality principles, gather and analyze quality data to support product/process improvement activities.
- Oversee manufacturing-related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations.
- Disposition non-conforming material and work with manufacturers and suppliers to implement corrective and preventive actions.
- Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
- Provide quality input into process validation activities.
Requirements:
- BE/BS Degree.
- A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
- At least three years Quality Engineering experience or related role within the medical device industry.
- Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.