Lead QA Engineer - Medical Devices & Manufacturing

Dexcom; San Diego (CA); On-site; USD 111,000 - 185,000; Full time

Benefits offered by this job

Full benefits

Career development

Tuition reimbursement

Travel opportunities

Job summary

Dexcom seeks a seasoned Quality Engineering leader to drive regulatory compliance and manufacturing readiness for high‑volume CGM automation systems. You will guide validation, risk management, and CAPA across global sites, partnering with operations to scale processes and ensure quality from pilot to production.

You will mentor teams, apply Six Sigma and data-driven analysis, and shape QMS improvements in a dynamic, global setting that aims to improve patient health outcomes and product

Qualifications

• Hands-on experience with FDA 21 CFR 820 and ISO 13485 in a QA/QMS capacity.
• Ability to interpret and apply complex regulatory requirements across programs.
• Strong root cause analysis and problem-solving skills, with data-driven decision making.

Responsibilities

• Lead qualification and design transfer strategies for new products.
• Guide validation strategies across programs and ensure manufacturing readiness.
• Mentor engineers and drive CAPA and process controls improvements.

Skills

FDA 21 CFR 820

ISO 13485

Quality systems

Root cause analysis

Six Sigma

Data analysis

Excel

JMP

Cross-functional leadership

Communication

Education

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD in technical discipline

Tools

Excel

JMP

Job description

Dexcom seeks a seasoned Quality Engineering leader to drive regulatory compliance and manufacturing readiness for high‑volume CGM automation systems. You will guide validation, risk management, and CAPA across global sites, partnering with operations to scale processes and ensure quality from pilot to production.

You will mentor teams, apply Six Sigma and data-driven analysis, and shape QMS improvements in a dynamic, global setting that aims to improve patient health outcomes and product