QA Engineer 2

QA Engineer 2

Dexcom

Athenry, Ireland

Our Quality Assurance team are looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As a QA Engineer, you will play an integral part of the in the validation and quality assurance of site equipment, utilities and processes in compliance with Dexcom procedures. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle.

Where you come in:

• You will coordinate and actively participate in the validation and quality assurance of site equipment, utilities and processes in compliance with Dexcom procedures. This will include equipment which have a high degree of automation;
• You will review validation protocols and final reports, ensuring they meet cGMP standards;
• You will manage validation investigations and implement corrective actions as needed;
• You will communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary;
• You will design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products;
• You will have an understanding of the concepts, principles, and techniques of statistics and how to apply these to datasets, identifying patterns and drawing actionable insights;
• You will participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems;
• You will review, update and maintain existing quality management processes and procedures;
• You will initiate non-conformances/CAPAs and complete investigations as required;
• Perform risk management activities (e.g., FMEA, risk assessments) to ensure the safety and effectiveness of products;
• You will be responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution;
• You will monitor and report on quality metrics, such as defect rates and process capability;
• Assumes and performs other duties as assigned.

What makes you successful:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience or Master’s degree and 0-2 years’ equivalent experience;
• You will have QA experience in process and equipment validation, with hands on experience in end-to- end process validation;
• Experience in automation validation of is highly desirable;
• You will be proficient Microsoft Office and database applications (e.g. Excel and MiniTab or similar);
• You will have critical thinking, solid decision making and problem-solving skills;
• You will have strong written and oral communication and presentation skills.