Senior Quality Engineer, Medical Device Validation

RXinsider LTD.; San Diego (CA); Hybrid; USD 87,000 - 145,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global growth opportunities

Career development programs

Job summary

Dexcom, a global leader in continuous glucose monitoring, seeks a senior quality engineer to lead investigations, CAPAs, and risk-based improvements across cross-functional teams. You will drive QMS excellence, validation strategies, and design transfers for new products while ensuring regulatory compliance and product safety throughout the lifecycle.

The role requires a technical degree and extensive experience in regulated manufacturing, with collaboration across R&D, Regulatory, and global

Qualifications

• Bachelor’s degree in a technical discipline with 5–8 years of related experience.
• Advanced quality engineering knowledge in risk management and statistical methods.
• Experience developing validation strategies (IQ/OQ/PQ/PV) and software V&V.
• Strong collaboration with R&D, Regulatory, Manufacturing, and global teams.

Responsibilities

• Lead complex quality investigations including root-cause analysis and CAPAs.
• Provide technical leadership in quality engineering and process improvement.
• Drive QMS excellence through procedures, controls, and validation frameworks.
• Own validation/qualification strategies for equipment, processes, and software.
• Represent QA on cross-functional projects with global teams.
• Guide design transfer and commercialization for new products.
• Assess risk and implement robust controls for regulatory compliance.
• Identify and close compliance gaps across sites.
• Communicate complex topics effectively to stakeholders.
• Support audits and regulatory inspections.

Skills

Root cause analysis

CAPA management

Six Sigma

Lean manufacturing

FMEA

Software V&V

Quality systems

Cross-functional leadership

Education

Bachelor's degree in a technical discipline

Master’s degree a plus

PhD a plus

Tools

JMP

Excel

Job description

Dexcom, a global leader in continuous glucose monitoring, seeks a senior quality engineer to lead investigations, CAPAs, and risk-based improvements across cross-functional teams. You will drive QMS excellence, validation strategies, and design transfers for new products while ensuring regulatory compliance and product safety throughout the lifecycle.

The role requires a technical degree and extensive experience in regulated manufacturing, with collaboration across R&D, Regulatory, and global