QA Engineer II - Automation

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Our Quality Assurance team is 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 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 has a high degree of automation.
• You will review validation protocols and final reports, ensuring they meet cGMP standards.
• You will handle validation investigations and implement corrective actions as needed.
• You will communicate regularly with peers and management regarding activities, raising 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 handling 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.

• You will have QA experience in process and equipment validation, with hands-on experience in end-to-end process validation.
• Experience in automation validation is highly desirable.
• You will be proficient in 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.

• A front row seat to life-changing CGM technology. Learn about our brave #dexcomwarriors community .
• 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.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

• 5%

• 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.