Quality Engineer Role
Location: Galway Business Park, Dangan
This is an exciting opportunity to join an early-stage medical device start-up company focused on designing and developing novel devices for the treatment of Intracranial Atherosclerotic Disease. The company is at the forefront of a new and evolving treatment area in Neuro-intervention.
Overview
This Quality Engineer position requires a proven track record in Quality Assurance and Regulatory control of medical devices. You will be responsible for ensuring product quality from early development phases through to commercial launch.
Main Responsibilities
* Ensure compliance with policies, procedures, and applicable national and international regulations.
* Lead compliance and improvement activities associated with the quality system (e.g., CAPA, audit programs, personnel training).
* Apply thorough problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality system audits.
* Act as an audit escort and support the coordination of backroom activities during inspections as required.
* Provide expertise in quality assurance, controls, and systems to develop and maintain the company's Quality Management System.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Work closely with suppliers to establish robust quality agreements, including periodic review of their quality metrics.
* Support internal teams in product development through first article inspection qualifications, test method development, and approval activities.
Requirements
* Bachelor's degree in engineering or a related technical field.
* Minimum 3 years of experience in Quality engineering within the medical device industry, preferably with neuro interventional devices.
* Strong understanding of basic engineering principles.