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Dexcom

Staff QA Engineer

Location
San Diego, CA (CA)
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Manufacturing/Quality
Industry
Medical Device
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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 approach is important as you navigate shifting priorities, technical ambiguity, and complex cross-functional decisions.

Where you come in:

  • You lead complex, high-risk quality investigations, including root cause analysis, CAPAs, NCMRs/MRB, Health Hazard Evaluations (HHEs), and other product and process risk assessments, driving appropriate disposition and sustainable corrective actions.
  • You provide technical leadership and guidance in quality engineering, including risk management, Six Sigma, process capability, statistical analysis, sampling strategies, and risk-based problem solving.
  • You drive Quality Management System excellence by identifying systemic weaknesses and leading sustainable improvements to procedures, process controls, validation frameworks, FMEAs, and other quality processes across functions or sites.
  • You define and provide technical leadership for risk-based validation and qualification strategies, including equipment and process qualification, Test Method Validation (TMV), measurement system analysis, and software V&V, ensuring compliance and product safety throughout the product lifecycle.
  • You serve as a quality engineering technical lead across complex cross-functional initiatives, communicating technical and compliance issues clearly through written documentation, oral communication, and presentations to technical teams and senior leadership, while driving decisions and alignment across functions and sites.
  • You provide risk-based quality leadership for design transfer, commercialization, and significant product or process changes, influencing technical decisions and establishing robust controls as products and processes scale to high-volume manufacturing.
  • You represent Quality during internal audits and external regulatory inspections, providing subject matter expertise, leading responses to complex technical issues, and helping shape organizational quality and compliance strategy.

What makes you successful:

  • Your Chemical Engineering or similar degree from an accredited college or university, with substantial quality engineering experience in regulated manufacturing environments.
  • Your advanced application of quality engineering principles, including risk management, root cause analysis, statistical analysis, process capability, sampling plans, measurement system analysis, and data-driven decision-making using tools such as JMP and Excel.
  • Your demonstrated experience developing and evaluating risk-based validation strategies, including IQ/OQ/PQ/PV, Test Method Validation (TMV), measurement system analysis/Gage R&R, and software V&V.
  • Your experience applying risk-based quality engineering to design transfer, commercialization, manufacturing issues, and process changes, with the ability to move between detailed technical problem solving and broader quality strategy.
  • Your advanced written, oral, and presentation skills, with the ability to distill complex technical information, communicate risk and recommendations clearly, influence without direct authority, and present confidently to technical teams, cross-functional stakeholders, and senior leadership.

…

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