Senior Quality Engineer

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 are looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As a Senior Quality 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 review, update, and maintain existing quality management processes and procedures.

• You will initiate non-conformances/CAPAs and complete investigations as required.
• 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 be involved in reviewing, implementing, and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products.
• You will perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• You will participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
• You will monitor and report on quality metrics, such as defect rates and process capability.
• You will perform risk management activities (e.g., FMEA, risk assessments) to ensure the safety and effectiveness of products.
• You will lead risk management, validation, sample size, and external standards review and implementation activities.
• You will assure compliance with in-house and/or external specifications and standards (i.e., GLP, GMP, ISO Six Sigma).
• You will be involved in designing 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 perform internal audits to ensure systems comply with requirements and are effective.
• You will communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.
• You will assume and perform other duties as assigned.

What makes you successful:

• You will have critical thinking, solid decision making and problem-solving skills.
• You will have strong written and oral communication and presentation skills.
• You will be proficient Microsoft Office and database applications (e.g. Excel and MiniTab or similar).
• QA experience in process and equipment validation is desirable but not essential.

What you’ll get:

• 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.

Travel Required:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.