Senior Quality Engineer, Medical Devices & Compliance

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

Job summary

Dexcom is seeking a Senior Quality Engineer in Mesa, AZ to lead cross‑functional quality initiatives across Operations, R&D, Regulatory, and Manufacturing. You will implement QA protocols, ensure compliance with GLP, GMP, ISO standards, and drive CAPA investigations and risk‑based decisions.

The role offers growth opportunities in a patient‑focused medical device environment. Expect to mentor engineers, strengthen quality systems, and influence product and process design with data‑driven

Qualifications

• Bachelor’s degree in a technical discipline with 5–8 years related experience, or Master’s degree with 2–5 years experience.
• Experience with FDA QSR, ISO 13485 and risk-management requirements.
• Strong leadership and data-driven decision making in a fast-paced environment.

Responsibilities

• Provide guidance across cross-functional teams.
• Implement and maintain quality assurance protocols and methods.
• Assure compliance to GLP, GMP, ISO and Six Sigma standards.
• Complete complex investigations, CAPA development, and quality decisions.
• Identify systemic issues and drive long-term preventive actions.

Skills

QSR knowledge

ISO 13485

Risk management

Statistical tools

Root cause analysis

Problem solving

Leadership

Education

Bachelor's degree

Master's degree

PhD

Tools

CAPA software

Statistical software

Job description

Dexcom is seeking a Senior Quality Engineer in Mesa, AZ to lead cross‑functional quality initiatives across Operations, R&D, Regulatory, and Manufacturing. You will implement QA protocols, ensure compliance with GLP, GMP, ISO standards, and drive CAPA investigations and risk‑based decisions.

The role offers growth opportunities in a patient‑focused medical device environment. Expect to mentor engineers, strengthen quality systems, and influence product and process design with data‑driven