Senior Quality Engineer – Cross-Functional Quality Leader

Dexcom Inc.

San Diego (CA)

Hybrid

USD 87,000 - 145,000

Full time

14 days+
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Job summary

Dexcom Inc. in San Diego seeks a Senior Quality Engineer to lead complex investigations, drive CAPAs and MRB decisions, and push systemic quality improvements. You will apply Six Sigma, Lean, and risk-based problem solving to enhance product quality and regulatory compliance across sites.

You will partner with R&D, Regulatory Affairs, Manufacturing, and global teams to ensure robust validation, design transfer, and scalable processes that protect patients and patients' health outcomes.

Qualifications

  • Bachelor’s degree in a technical discipline with regulated manufacturing experience.
  • Advanced quality engineering knowledge and data-driven decision-making.
  • Experience validating and qualifying equipment, processes, and test methods.

Responsibilities

  • Lead complex quality investigations and drive root cause analysis.
  • Own CAPAs, MRB/disposition decisions, and systemic improvements.
  • Provide technical leadership in Six Sigma, Lean, and risk-based solving.
  • Direct validation strategies for equipment, processes, test methods, and software V&V.
  • Collaborate with R&D, Regulatory, Manufacturing, and global teams on quality solutions.
  • Support design transfer and commercialization with risk-informed decisions.
  • Communicate complex topics clearly across organizational levels.

Skills

Root cause analysis
CAPA leadership
Six Sigma
Process capability (Cpk/Ppk)
Gage R&R
Sampling plans
Risk-based problem solving
Data analysis (JMP, Excel)
Design transfer
Regulatory compliance awareness

Education

Bachelor’s degree in Chemical Engineering or similar

Tools

JMP
Excel

Job description

Dexcom Inc. in San Diego seeks a Senior Quality Engineer to lead complex investigations, drive CAPAs and MRB decisions, and push systemic quality improvements. You will apply Six Sigma, Lean, and risk-based problem solving to enhance product quality and regulatory compliance across sites.

You will partner with R&D, Regulatory Affairs, Manufacturing, and global teams to ensure robust validation, design transfer, and scalable processes that protect patients and patients' health outcomes.

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