Senior Quality Engineer — Lead Medical Device Quality

Dexcom, Inc; Mesa (AZ); On-site; USD 87,000 - 145,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development

Tuition reimbursement

Job summary

Dexcom seeks a Senior Quality Engineer to lead investigations, CAPA development, and strengthen quality systems across cross-functional teams. You will influence product design and drive data-driven decisions to ensure safety, reliability, and regulatory compliance of medical devices.

The role requires deep knowledge of FDA QSR, ISO 13485, and risk management; you will mentor engineers, reinforce quality processes, and partner with operations, R&D, and manufacturing to deliver compliant devices

Qualifications

• Bachelor's degree in a technical field with 5-8 years of related experience, or higher degrees with fewer years.
• Experience in quality engineering within medical devices is preferred.
• Knowledge of FDA QSR, ISO 13485, and risk management required.

Responsibilities

• Lead complex investigations and CAPA development.
• Develop and strengthen quality systems and drive data-driven decisions.
• Mentor engineers and promote risk-based thinking.
• Ensure products meet safety, reliability, and regulatory standards.

Skills

FDA QSR

ISO 13485

Risk management

Statistical tools

Root cause analysis

Validation

Problem solving

Leadership presence

Communication skills

Prioritization

Education

Bachelor's degree in a technical discipline

Tools

GLP

GMP

ISO 13485

Job description

Dexcom seeks a Senior Quality Engineer to lead investigations, CAPA development, and strengthen quality systems across cross-functional teams. You will influence product design and drive data-driven decisions to ensure safety, reliability, and regulatory compliance of medical devices.

The role requires deep knowledge of FDA QSR, ISO 13485, and risk management; you will mentor engineers, reinforce quality processes, and partner with operations, R&D, and manufacturing to deliver compliant devices