QA Engineering Leader, Manufacturing Automation

Dexcom Inc.; Northern, San Diego (KY, CA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Dexcom is seeking a Senior Manager of QA Engineering in San Diego, CA to lead a team delivering high-volume manufacturing automation, qualification, and process validation. You will ensure quality systems meet FDA and ISO requirements while enabling scalable manufacturing across programs.

The role requires 13+ years in the industry, 5–8 years of people management, and strong leadership in Design Control, Process Validation, and risk management.

Qualifications

• Bachelor's degree in a technical discipline; 13+ years of industry experience.
• 5–8 years of people management experience.
• Experience with FDA 21 CFR 820 and ISO 13485.
• Experience with Design Control, Process Validation, and CAPA.

Responsibilities

• Lead a team of Quality Engineers across manufacturing operations.
• Oversee Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities.
• Ensure regulatory compliance and audit readiness across sites and programs.
• Drive continuous improvement using quality metrics, CAPA effectiveness, and risk-based decision making.
• Collaborate with Engineering, Operations, and R&D leaders to mitigate risks and enable scalable manufacturing.

Skills

Leadership

Regulatory knowledge

Quality engineering

Process improvement

Risk management

Education

Bachelor's degree in a technical discipline

Job description

Dexcom is seeking a Senior Manager of QA Engineering in San Diego, CA to lead a team delivering high-volume manufacturing automation, qualification, and process validation. You will ensure quality systems meet FDA and ISO requirements while enabling scalable manufacturing across programs.

The role requires 13+ years in the industry, 5–8 years of people management, and strong leadership in Design Control, Process Validation, and risk management.