Senior QA Engineering Manager: Manufacturing Automation

1 DexCom Inc; San Diego (CA); On-site; USD 142,000 - 236,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global growth opportunities

Career development programs

Job summary

Dexcom is seeking a Senior Manager, QA Engineering to lead a team responsible for high-volume manufacturing automation equipment, product introductions, and process validation. You will drive quality, compliance, and risk management across programs and sites.

You will establish strategic direction for quality activities, ensuring alignment with regulatory requirements and business goals, while mentoring teams and partnering with Engineering, Operations, and R&D to deploy advanced manufacturing

Qualifications

• Experience leading Quality Engineering teams in a regulated environment.
• Deep knowledge of FDA 21 CFR 820, ISO 13485, Design Controls, Process Validation, Risk Management, and QMS.

Responsibilities

• Lead a team of Quality Engineers supporting high-volume manufacturing automation equipment.
• Oversee Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities.
• Ensure compliance with regulatory requirements and prepare for inspections and audits.
• Drive continuous improvement through quality metrics, CAPA effectiveness, and systemic problem-solving.

Skills

Leadership

Quality Engineering

Regulatory Compliance

Process Validation

Risk Management

Quality Metrics

CAPA

Cross-functional Collaboration

Data-driven Decision Making

Education

Bachelor’s degree in a technical discipline

Job description

Dexcom is seeking a Senior Manager, QA Engineering to lead a team responsible for high-volume manufacturing automation equipment, product introductions, and process validation. You will drive quality, compliance, and risk management across programs and sites.

You will establish strategic direction for quality activities, ensuring alignment with regulatory requirements and business goals, while mentoring teams and partnering with Engineering, Operations, and R&D to deploy advanced manufacturing