Company Overview
Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded 25 years ago with the mission to transform diabetes management, Dexcom now aims to empower people to take control of their health through personalized, actionable insights. We are committed to improving human health on a global scale by developing innovative biosensing technologies.
Our team of passionate professionals worldwide is dedicated to earning customer trust through integrity, service, and innovation. We aspire to become a leading consumer health technology company, expanding our solutions for serious health conditions and continuously reinventing our biosensing experiences.
Meet The Team
Our Quality Assurance team is seeking a QA Engineer to support the startup of our first European manufacturing site in Athenry. This role is vital in validating and ensuring the quality of site equipment, utilities, and processes in compliance with Dexcom procedures. As part of this dynamic team, you will collaborate across functions and gain broad exposure to the entire product lifecycle.
Responsibilities
1. Coordinate and participate in validation and quality assurance activities for site equipment, utilities, and processes, including highly automated equipment.
2. Review validation protocols and final reports to ensure compliance with cGMP standards.
3. Manage validation investigations and implement corrective actions as necessary.
4. Communicate regularly with peers and management, escalating issues as needed.
5. Design inspection, testing, and evaluation methods for production processes, equipment, and finished products.
6. Apply statistical principles to datasets to identify patterns and derive insights.
7. Participate in continuous improvement initiatives to enhance manufacturing, quality, safety, and training systems.
8. Review, update, and maintain quality management processes and procedures.
9. Initiate non-conformances and CAPAs, conducting investigations as required.
10. Perform risk assessments (e.g., FMEA) to ensure product safety and efficacy.
11. Plan and manage compliance of manufacturing processes with safety, quality, and regulatory standards for global distribution.
12. Monitor and report on quality metrics such as defect rates and process capability.
13. Perform other duties as assigned.
Qualifications
* QA experience in process and equipment validation, including end-to-end validation.
* Experience in automation validation is highly desirable.
* Proficiency in Microsoft Office and database applications (e.g., Excel, MiniTab).
* Strong critical thinking, decision-making, and problem-solving skills.
* Excellent written and oral communication and presentation skills.
Benefits
* Opportunity to work with life-changing CGM technology and be part of our #dexcomwarriors community.
* Comprehensive benefits package.
* Global growth opportunities.
* Access to career development programs and tuition reimbursement.
* Join an innovative organization committed to employees, customers, and communities.
Travel Requirements
* Approximately 5% travel.
Experience and Education
* Bachelor’s degree in a technical discipline with 2-5 years of related experience, or Master’s degree with 0-2 years of experience.
#J-18808-Ljbffr