Staff QA Engineer — Global Quality & Validation

RXinsider LTD.; San Diego, Northern (CA, KY); Hybrid; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global growth opportunities

Career development programs

Tuition reimbursement

Job summary

Dexcom Corporation is seeking a seniorQuality Engineering leader to drive design transfer and ensure scalable, compliant manufacturing for CGM technology. You will partner with global operations to pass audits, lead investigations, and govern the Quality Management System across programs.

You will mentor engineers, apply Six Sigma and statistical methods, and guide CAPA strategies while delivering robust, data-driven decisions in a fast-paced, cross-functional environment.

Qualifications

• Experience interpreting FDA 21 CFR 820 and ISO 13485 requirements at system/program level.
• Ability to review engineering docs, drawings, specifications, and guide others.
• Advanced root cause analysis and structured problem solving skills.
• Strong data-driven decision making using Excel/JMP.

Responsibilities

• Lead design control and design transfer strategy for high-volume manufacturing.
• Provide quality engineering leadership across development, validation, and commercialization of new processes.
• Guide investigations, MRB decisions, and systemic improvements in equipment and processes.
• Align multi-site teams on regulatory and quality topics and drive corrective actions.

Skills

FDA 21 CFR 820

ISO 13485

Quality Management System

Root Cause Analysis

Six Sigma

Statistical Analysis

Excel

JMP

Communication

Leadership

Mentoring

Education

Bachelor’s degree in a technical discipline

Master’s degree or PhD (advantage)

Tools

Excel

JMP

Job description

Dexcom Corporation is seeking a seniorQuality Engineering leader to drive design transfer and ensure scalable, compliant manufacturing for CGM technology. You will partner with global operations to pass audits, lead investigations, and govern the Quality Management System across programs.

You will mentor engineers, apply Six Sigma and statistical methods, and guide CAPA strategies while delivering robust, data-driven decisions in a fast-paced, cross-functional environment.