Sr QA Engineer

DexcomSan Diego, CA
$87,000 - $145,000

About The Position

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.

Requirements

  • Chemical Engineering or similar degree from accredited College/University with experience supporting regulated manufacturing environments.
  • Advanced quality engineering knowledge, including risk management, root cause analysis, Six Sigma, process capability analysis (Cpk/Ppk), statistical analysis, sampling plans, AQL, and data-driven decision-making.
  • Demonstrated experience developing and executing validation strategies, including IQ/OQ/PQ/PV, test method validation, software V&V, and process validation activities.
  • Proficiency in design transfer and commercialization, applying risk-based decision making to successfully transition new products and processes from development into high-volume manufacturing.
  • Strong technical aptitude with a hands-on approach, partnering directly with manufacturing teams to assess risk, troubleshoot issues, and drive sustainable process improvements.
  • Proficiency with data analysis tools such as JMP and Excel, leveraging data to generate actionable insights that support business and quality objectives.
  • Ability to communicate complex technical and compliance topics effectively across all organizational levels, influencing stakeholders and presenting confidently to senior leadership.
  • Cross-functional leadership, building alignment across Engineering, Operations, R&D, Regulatory Affairs, and global teams to deliver comprehensive quality solutions.
  • Experience with chemistry in manufacturing and associated risks (polymers and analytical experience preferred).
  • Strong ownership, integrity, and organizational agility, successfully managing multiple high-priority initiatives while driving strategic quality and compliance improvements in a fast-paced environment.

Nice To Haves

  • Polymers and analytical experience preferred.

Responsibilities

  • Lead complex quality investigations by driving root cause analysis, CAPAs, NCMRs (including MRB/disposition decision-making), and systemic corrective actions that improve product quality and compliance.
  • Provide technical leadership in quality engineering and continuous improvement methodologies, including Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, and risk-based problem solving.
  • Drive Quality Management System excellence through continuous improvement of procedures, process controls, validation frameworks, FMEAs, and quality processes.
  • Own validation and qualification strategies for equipment, processes, test methods, and software V&V, ensuring compliance and product safety throughout the product lifecycle.
  • Serve as the quality engineering lead on cross-functional projects, partnering closely with R&D, Regulatory Affairs, Manufacturing, Operations, Engineering, and global teams to achieve successful business outcomes.
  • Guide design transfer and commercialization efforts, ensuring new products and processes are successfully scaled from development through high-volume manufacturing.
  • Assess and mitigate risk by influencing design decisions, evaluating process changes, and implementing robust controls that ensure reliable product performance and regulatory compliance.
  • Identify and close compliance gaps by proactively assessing quality system weaknesses and leading sustainable corrective and preventive actions across sites and functions.
  • Communicate complex technical and compliance topics effectively through effective written and verbal communication, influencing stakeholders and driving alignment across cross-functional and international teams.
  • Represent Quality during internal audits and external regulatory inspections, providing subject matter expertise and helping shape organizational quality and compliance strategy.

Benefits

  • 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.
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