QA 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:

Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcom’s products. Our quality engineering team plays a crucial role in cross-site and cross-functional alignment for the future of Dexcom and for the future of our customers’ health. You will support Dexcom in bringing state-of-the-art innovative technology to patients and will help to define, support, and improve the processes that get us there.

A positive and team-oriented attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Where you come in:

You support and independently execute quality investigations, including root cause analysis, CAPAs, NCMRs, and MRB/disposition activities, and implement corrective actions that improve product quality and compliance.

You apply quality engineering and continuous improvement methodologies, such as Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, and risk-based problem solving.

You support the effectiveness and continuous improvement of the Quality Management System through updates to procedures, process controls, validation practices, FMEAs, and other quality processes.

You develop, review, and execute validation and qualification documentation for equipment, processes, test methods, and software, following applicable procedures and regulatory requirements.

You provide quality engineering support for cross-functional projects, partnering with R&D, Regulatory Affairs, Manufacturing, Operations, Engineering, and global teams to meet project and quality objectives.

You support design transfer and commercialization activities by reviewing requirements, evaluating manufacturing readiness, identifying quality risks, and helping transition new products and processes into manufacturing.

You perform and document risk assessments, evaluate process and design changes, and recommend appropriate controls to support product performance and regulatory compliance.

You represent Quality during audits and inspections within your assigned areas of responsibility.

What makes you successful:

Your Engineering, Chemistry or similar degree from accredited College/University with experience supporting regulated manufacturing environments.

Your quality engineering knowledge, including risk management, root cause analysis, Six Sigma, process capability analysis (Cpk/Ppk), statistical…