Senior Quality Engineer — Lead Quality for CGM

Regulatory Jobs; Mesa (AZ); On-site; USD 87,000 - 145,000; 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 Senior Quality Engineer to lead cross‑functional quality initiatives, strengthen quality systems, and ensure compliance with regulatory standards. The role emphasizes investigations, CAPA, and data‑driven decision making to deliver safe, effective medical devices.

Ideal candidates have a technical degree with extensive experience in QA, FDA QSR, ISO 13485, and risk management, and possess strong leadership and communication skills in a fast‑paced environment.

Qualifications

• Bachelor’s degree in a technical discipline is typically required.
• 5–8 years related experience or a Master’s degree with 2–5 years; a PhD with 0–2 years is acceptable.
• Strong knowledge of FDA QSR, ISO 13485 and risk-management requirements.

Responsibilities

• Guide cross‑functional teams in quality initiatives across the organization.
• Implement and maintain quality assurance protocols for processing materials into finished products.
• Ensure compliance to internal and external specifications (GLP, GMP, ISO, Six Sigma).
• Complete complex investigations, CAPA development, and quality decision-making.
• Assist in high‑visibility quality engineering projects with cross‑functional teams.
• Identify systemic issues and drive long‑term corrective and preventive actions.

Skills

FDA QSR

ISO 13485

risk management

statistics

root cause analysis

validation

problem solving

leadership

communication

coaching

Education

Bachelor’s degree in a technical discipline

Master’s degree in a technical field

PhD with 0-2 years experience

Job description

Dexcom Corporation is seeking a Senior Quality Engineer to lead cross‑functional quality initiatives, strengthen quality systems, and ensure compliance with regulatory standards. The role emphasizes investigations, CAPA, and data‑driven decision making to deliver safe, effective medical devices.

Ideal candidates have a technical degree with extensive experience in QA, FDA QSR, ISO 13485, and risk management, and possess strong leadership and communication skills in a fast‑paced environment.