Senior QA Engineer - Medical Devices & Quality Systems

Dexcom, Inc.

Mesa (AZ)

On-site

USD 72,000 - 119,000

Full time

4 days ago
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Benefits offered by this job

Comprehensive benefits
Global growth opportunities
Career development programs

Job summary

Dexcom, Inc. in Mesa, AZ is seeking a Quality Engineer II to lead investigations, strengthen quality systems, and drive risk‑based decisions across manufacturing and design.

You will mentor engineers, apply FDA QSR and ISO 13485 guidelines, and partner with cross‑functional teams to ensure devices meet safety, reliability, and regulatory standards while delivering continuous improvement.

Qualifications

  • Bachelor’s degree in a technical discipline and 2–5 years of related experience, or Master’s degree and 0–2 years of equivalent industry experience.
  • Understanding FDA QSR, ISO 13485, and risk‑management requirements.
  • Experience with statistical tools and root cause analysis.
  • Strong communication in technical and non‑technical audiences.
  • Ability to thrive in a fast‑paced environment and manage multiple priorities.

Responsibilities

  • Lead complex investigations into nonconformances and drive corrective actions.
  • Develop and strengthen quality systems across product lifecycle.
  • Influence design and process improvements to meet regulatory and performance requirements.
  • Mentor engineers and promote risk‑based thinking across cross‑functional teams.
  • Identify systemic issues and guide long‑term CAPA actions.

Skills

Quality systems
Root cause analysis
Statistical tools
FDA QSR
Cross-functional leadership

Education

Bachelor’s degree in a technical discipline
Master’s degree (advantage)

Job description

Dexcom, Inc. in Mesa, AZ is seeking a Quality Engineer II to lead investigations, strengthen quality systems, and drive risk‑based decisions across manufacturing and design.

You will mentor engineers, apply FDA QSR and ISO 13485 guidelines, and partner with cross‑functional teams to ensure devices meet safety, reliability, and regulatory standards while delivering continuous improvement.

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