Senior QA Engineer — Quality & Compliance Leader

Dexcom Inc.; San Diego (CA); On-site; USD 87,000 - 145,000; Full time

Job summary

Dexcom Inc. in San Diego is seeking a Quality Engineering Lead to drive complex quality investigations, CAPAs, and systemic improvements across the product lifecycle.

You will lead cross-functional teams with R&D, Regulatory, Manufacturing, and global partners to ensure product safety and compliance. You will own validation strategies for equipment, processes, test methods, and software V&V, applying Six Sigma and risk-based decision making to optimize quality systems and manufacturing

Qualifications

• Bachelor’s degree in a technical discipline; 5–8 years related experience, or Master’s 2–5 years, or PhD 0–2 years.
• Experience supporting regulated manufacturing environments.
• Experience leading quality investigations, CAPAs, and MRB/disposition decisions.
• Strong background in Six Sigma, risk-based problem solving, and data-driven decision making.

Responsibilities

• Lead complex quality investigations by driving root cause analysis, CAPAs, NCMRs, and corrective actions.
• Provide technical leadership in quality engineering and continuous improvement methodologies.
• Drive QMS excellence through procedures, process controls, validation frameworks, FMEAs, and quality processes.
• Own validation and qualification strategies for equipment, processes, test methods, and software V&V.
• Serve as quality engineering lead on cross-functional projects with R&D, Regulatory, Manufacturing, and global teams.
• Guide design transfer and commercialization to scale from development to high-volume manufacturing.
• Assess and mitigate risk by influencing design decisions and implementing robust controls.
• Identify and close compliance gaps by addressing quality system weaknesses and initiating CAPAs.

Skills

Root cause analysis

Six Sigma

Process capability

Statistical analysis

JMP & Excel

Cross-functional leadership

Quality systems

Design transfer

Education

Bachelor’s degree in technical discipline

Master’s degree

PhD

Tools

Gage R&R

FMEA

IQ/OQ/PQ

Software V&V

Job description

Dexcom Inc. in San Diego is seeking a Quality Engineering Lead to drive complex quality investigations, CAPAs, and systemic improvements across the product lifecycle.

You will lead cross-functional teams with R&D, Regulatory, Manufacturing, and global partners to ensure product safety and compliance. You will own validation strategies for equipment, processes, test methods, and software V&V, applying Six Sigma and risk-based decision making to optimize quality systems and manufacturing