Sr QA Engineer

Sr QA Engineer – Dexcom

Dexcom Corporation (NASDAQ: DXCM) is a global leader in continuous glucose monitoring (CGM). Founded to change diabetes management and now expanding into broader consumer health technology, Dexcom partners with thousands of passionate people worldwide to improve health outcomes.

As a Senior Quality Assurance Engineer, you will execute and coordinate Corrective and Preventive Actions (CAPA), Health Hazard Assessments (HHA/HHE), Non‑Conforming Events (NCE), support audits, define requirements, and develop analytics dashboards. You will collaborate with cross‑functional teams including Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Regulatory Affairs, and more to ensure compliance with Dexcom’s Quality Management System and international regulatory standards (21 CFR Parts 11, 801, 803, 820;

ISO 13485, 14971).

• Lead and coordinate CAPA, HHA, and NCE processes; guide investigations and approvals of corrective actions.
• Prepare agendas and minutes for QA Review Board meetings.
• Design, develop, validate, and deploy Quality Assurance metric dashboards for Operations Quality Assurance.
• Drive QA continuous improvement projects and, when required, administer specific quality system aspects.
• Create and enforce company policies and procedures to support domestic and international compliance (e.g., validation, audits, calibrations, CAPA, customer complaints, document control, non‑conforming materials, process controls, receiving inspection, training).
• Participate in internal and supplier audits to ensure system effectiveness.
• Assist design team activities: define design inputs, design components and processes, verify that outputs meet inputs.
• Apply risk management, validation, sample‑size, and external standards to product development.
• Coordinate disposition of nonconforming materials with the Materials Review Board.
• Read, write, and understand specifications and inspection criteria, applying appropriate tools.

• Direct experience with Quality Management Systems, CAPA, HHA/HHE, NCE, internal & external audits.
• Experience with FDA audits and a strong understanding of QMS in medical devices.
• Collaborative leader who can work autonomously and with diverse functional groups.
• Excellent judgment in selecting problem‑solving methods and achieving solutions.
• Positive attitude in a fast‑paced environment with shifting priorities.
• Familiarity with Oracle, Camstar, IQVIA, 1
  
  Factory, EtQ Reliance, Korber, SQL Server, Power BI, Tableau.
• Proficiency with statistical analysis software such as Minitab and JMP.
• Certified Quality Engineer or Certified Quality Auditor is a plus.

• Front‑row seat to life‑changing CGM technology and the Dexcom warrior community.
• Comprehensive benefits program.
• Global growth opportunities.
• Career development through in‑house learning programs and qualified tuition reimbursement.
• Innovative, industry‑leading organization committed to employees, customers, and communities.

0‑5 % travel required.

• Bachelor’s degree in a technical discipline with 5‑8 years of related industry experience, or Master’s with 2‑5 years, or PhD with 0‑2 years.

$87,000.00 – $

Dexcom is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Reasonable accommodations may be provided to qualified individuals with disabilities.

For more information, please contact Dexcom Talent Acquisition at .