Sr QA Engineer

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 and to unlock information and insights that drive better health outcomes. 25 years later we have pioneered an industry and are broadening our vision beyond diabetes to empower people to take control of health. Our ambition is to become a leading consumer health technology company while continuously reinventing unique biosensing‑technology experiences to improve human health worldwide.

We are driven by a passion for listening, serving with integrity, thinking big, and being dependable. Our goal is to change millions of lives by developing solutions for serious health conditions and creating personalized actionable insights.

As a Senior QA Engineer your role will be responsible for executing and coordinating Corrective and Preventive Actions (CAPA), Health Hazard Assessments (HHA/HHE), Non‑Conforming Events (NCE), supporting Internal and External Audits, defining requirements and aiding in the development of analytic dashboards, validating, and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development.

This position will interface with cross‑functional groups including Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, and Regulatory Affairs.

• Lead and coordinate CAPA, HHA and NCE systems, ensure compliance, guide investigations, assess effectiveness, and prepare QA Review Board agendas and minutes.
• Guide and maintain the CAPA process including investigation, root cause analysis, corrective/preventive actions and effectiveness verification.
• Ensure CAPA activities are completed thoroughly, timely, and with objective evidence.
• Facilitate investigations using rigorous, science‑based methodologies such as 5 Why, Fishbone, Fault Tree Analysis, DMAIC.
• Design and apply company policies and procedures to support quality policy and compliance with domestic and international regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 11, 801, 803, 820).
• Participate in internal and supplier audits to ensure system effectiveness.
• Apply risk management, validation, sample size determination, and external standards review and implementation activities.
• Read, write, and understand specifications and inspection criteria to apply appropriate inspection tools.
• Assume additional duties as assigned.

• Direct experience with Quality Management Systems, Non‑conforming Material, CAPA, HHA/HHE, Non‑conforming Events, Internal and External Audits.
• Experience with FDA audits.
• Good understanding of QMS as applied to medical devices.
• Collaborative, able to work effectively and lead diverse functional groups.
• Demonstrates good judgment in selecting methods and techniques for problem solving.
• Can work well independently with limited day‑to‑day instruction.
• Positive attitude in a fast‑paced, shifting‑priority environment.
• Experience with Oracle, Camstar, IQVIA, 1
  
  Factory, EtQ Reliance, Korber, SQL Server, Power BI, Tableau.
• Experience with statistical analysis software such as Minitab and JMP.
• Certified Quality Engineer or Certified Quality Auditor is a plus.

• A front‑row seat to life‑changing CGM technology and the Dexcom warrior community.
• 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.
• Work for an innovative, industry‑leading organization committed to employees, customers and communities.

• 0‑5%

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

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120 km). If you…