Senior Quality Engineer - Manufacturing & Compliance

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

Benefits offered by this job

Comprehensive benefits package

Global growth opportunities

Career development programs

Access to innovative CGM technology

Job summary

Dexcom seeks a senior quality engineering leader to drive regulatory compliance and manufacturing quality in high-volume automation. You will shape validation strategies, oversee design transfer, and guide complex investigations across global sites.

You will mentor teams, lead CAPA programs, and strengthen the Quality Management System in support of Dexcom’s CGM innovations and patient impact.

Qualifications

• Bachelor’s degree in a technical discipline with 8–12 years of related experience, or Master’s with 5–7 years, or PhD with 2–4 years.
• Experience applying FDA/ISO requirements to design transfer and process validation.
• Demonstrated leadership in cross-functional teams and audits.

Responsibilities

• Lead regulatory compliance and quality engineering for high-volume manufacturing.
• Architect validation strategies and oversee design transfer to manufacturing sites.
• Steer investigations, CAPA, MRB decisions, and systemic improvements.
• Coordinate cross-site alignment on complex quality and compliance topics.

Skills

FDA 21 CFR 820

ISO 13485

Quality management

Root-cause analysis

Six Sigma

Data analysis (Excel/JMP)

Cross-functional leadership

Regulatory inspections

Design transfer

Education

Bachelor's degree in a technical discipline

Master's degree

PhD

Tools

Excel

JMP

Job description

Dexcom seeks a senior quality engineering leader to drive regulatory compliance and manufacturing quality in high-volume automation. You will shape validation strategies, oversee design transfer, and guide complex investigations across global sites.

You will mentor teams, lead CAPA programs, and strengthen the Quality Management System in support of Dexcom’s CGM innovations and patient impact.