About Dexcom Inc.
Dexcom Inc. is a pioneering company in continuous glucose monitoring (CGM). Founded with a bold vision, our goal has remained the same: to revolutionize diabetes management and unlock insights that drive better health outcomes.
For 25 years, we've led the industry with innovative solutions. Our ambition now extends beyond diabetes, empowering individuals to take control of their health through personalized, actionable insights. We're committed to solving important health challenges and improving human well-being.
We're driven by a global community of passionate individuals who share our values: listening, integrity, thinking big, and dependability. Together, we've changed millions of lives and are poised to change many more. As we expand into new areas, we remain dedicated to developing solutions for serious health conditions using cutting-edge biosensing technology.
Meet Our Team:
Our Quality Assurance team is seeking a talented Quality Engineer to support the launch of our first European manufacturing site in Athenry. This role is crucial in validating and ensuring the quality of site equipment, utilities, and processes, aligning with Dexcom's procedures. You'll be part of a dynamic team that collaborates across multiple functions, gaining exposure to our entire product life cycle.
Your Key Responsibilities:
* 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 plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
* You will review, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
* You will analyze 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 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 statistical concepts, principles, and techniques, applying them to datasets to identify patterns and draw 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.
Your Success Factors:
* Critical thinking, solid decision making, and problem-solving skills.
* Strong written and oral communication and presentation skills.
* Proficiency in Microsoft Office and database applications (e.g., Excel and MiniTab or similar).
* Desirable but not essential: QA experience in process and equipment validation.
Your Benefits:
* A front-row seat to life-changing CGM technology and our brave #dexcomwarriors community.
* A 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, innovative, and industry-leading organization committed to its employees, customers, and communities.
Travel Required:
* 5-15%
Experience and Education Requirements:
* 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.