Quality Assurance Engineer
* Job Description:
About Dexcom is a global leader in continuous glucose monitoring. We began as a small company with a big dream: to change how diabetes is managed.
We are driven by thousands of passionate people worldwide who listen, serve with integrity, think big, and are dependable. Our ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions.
Meet the Team:
Our Quality Assurance team is looking for the right teammate to support the start-up of our first European manufacturing site. As a QA Engineer, you will play an integral part of validating and ensuring quality assurance of site equipment, utilities, and processes in compliance with procedures.
* Coordinate and actively participate in validation and quality assurance of site equipment, utilities, and processes in compliance with procedures.
* Review validation protocols and final reports, ensuring they meet cGMP standards.
* Manage validation investigations and implement corrective actions as needed.
* Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.
* Design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products.
* Have an understanding of statistics concepts, principles, and techniques and apply them to datasets, identifying patterns and drawing actionable insights.
* Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
* Review, update, and maintain existing quality management processes and procedures.
* 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.
* 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.
* Monitor and report on quality metrics, such as defect rates and process capability.
Requirements:
* QA experience in process and equipment validation, with hands-on experience in end-to-end process validation.
* Experience in automation validation is highly desirable.
* Proficient in Microsoft Office and database applications (e.g., Excel and MiniTab or similar).
* Critical thinking, solid decision-making, and problem-solving skills.
* Strong written and oral communication and presentation skills.
Working at Dexcom
We offer a front-row seat to life-changing CGM technology. Learn about our 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 employees, customers, and communities we serve.