Job Description
We are seeking a highly skilled Quality Engineer to join our team in Cork. As a key member of our organization, you will be responsible for ensuring compliance with relevant regulations and company quality management systems.
Main Responsibilities
* Ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations.
* Provide quality engineering support for new product development, manufacturing, and post-market activities.
* Participate in risk management activities including FMEAs, hazard analysis, and control strategies.
* Drive root cause analysis and implement effective corrective actions (CAPA).
* SUPPORT validation and qualification activities (processes equipment software test methods).
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