Senior QA Engineering Leader - Automation and Compliance

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

Job summary

Dexcom seeks a Senior Manager, QA Engineering to lead a team responsible for development, qualification, validation, and implementation of high-volume manufacturing automation equipment across multiple programs and sites.

You will drive quality, compliance, risk management, and continuous improvement while partnering with Engineering, Operations, and R&D to ensure scalable, compliant commercialization of new products.

Qualifications

• Bachelor's degree in a technical discipline required.
• 13+ years of industry experience.
• 5-8 years of people management experience.
• Strong knowledge of FDA 21 CFR 820 and ISO 13485.

Responsibilities

• Lead and develop a team of Quality Engineers for high-volume manufacturing automation equipment.
• Provide strategic direction for Quality Engineering activities across programs and sites.
• Oversee Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities.
• Drive continuous improvement, CAPA effectiveness, and risk management across the product lifecycle.
• Represent QA in internal and regulatory audits and inspections.

Skills

Leadership

Regulatory knowledge

Quality systems

Data-driven decision making

Cross-functional collaboration

Education

Bachelor's degree in technical discipline

Tools

FDA 21 CFR 820

ISO 13485

Job description

Dexcom seeks a Senior Manager, QA Engineering to lead a team responsible for development, qualification, validation, and implementation of high-volume manufacturing automation equipment across multiple programs and sites.

You will drive quality, compliance, risk management, and continuous improvement while partnering with Engineering, Operations, and R&D to ensure scalable, compliant commercialization of new products.