Quality Assurance Engineer Role
The company is seeking a highly skilled Quality Assurance Engineer to support the start-up of our first European manufacturing site in Athenry. This is an exciting opportunity for a talented individual to join our dynamic and highly effective team, playing an integral part in the validation and quality assurance of site equipment, utilities, and processes.
This role requires close collaboration across multiple functions, gaining broad exposure to our entire product life cycle. As a Quality Assurance Engineer, you will be responsible for coordinating and actively participating in the validation and quality assurance of site equipment, utilities, and processes, ensuring compliance with procedures and regulatory standards.
Responsibilities:
* Coordinate and participate in the validation and quality assurance of site equipment, utilities, and processes
* Review validation protocols and final reports to ensure they meet cGMP standards
* Manage validation investigations and implement corrective actions as needed
* Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary
* Design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products
Requirements:
* QA experience in process and equipment validation, with hands-on experience in end-to-end process validation
* Proficiency in Microsoft Office and database applications (e.g., Excel and MiniTab or similar)
* Critical thinking, solid decision-making, and problem-solving skills
* Strong written and oral communication and presentation skills
What We Offer:
* A front-row seat to life-changing CGM technology
* A full and comprehensive benefits program
* Growth opportunities on a global scale
* Access to career development through in-house learning programs and/or qualified tuition reimbursement
Travel Required:
5%
To excel in this role, you must have a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience, or a Master's degree and 0-2 years' equivalent experience.