Quality Engineer II
We are seeking a Quality Engineer II to join our medical device start-up in Galway.
Key Responsibilities:
* Ensure product quality during early development phases through to commercial launch.
* Develop and implement quality control processes, including batch release, internal audits, and supplier management.
* Collaborate with cross-functional teams to identify and mitigate quality risks.
Requirements:
* 3+ years of experience in Quality and Regulatory control of medical devices.
* Background in quality engineering, test reporting, batch release, first article inspections (FAI), data collection for sample testing, and supplier qualification and evaluation processes.
* Strong understanding of Quality Management System (QMS) principles and regulatory requirements.