Senior QA Engineering Manager – Automation & Compliance

Dexcom

San Diego (CA)

On-site

USD 142,000 - 236,000

Full time

2 days ago
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Benefits offered by this job

Competitive benefits
Growth opportunities
Tuition reimbursement

Job summary

Dexcom is seeking a Senior Manager, QA Engineering to lead a team responsible for the development, qualification, validation, and deployment of high-volume manufacturing automation equipment. You will ensure regulatory compliance and drive quality across product lifecycles.

You will collaborate with Engineering, Operations, and R&D to mitigate risks, improve CAPA processes, and advance quality metrics, with a strong emphasis on scalable, compliant manufacturing and continuous improvement.

Qualifications

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

Responsibilities

  • Lead and develop a team of Quality Engineers for manufacturing automation and new product introductions.
  • Set strategic direction for quality engineering activities aligned with regulatory requirements and business goals.
  • Oversee Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities for scalable commercialization.
  • Partner with Engineering, Operations, and R&D to mitigate quality, compliance, and business risks.
  • Drive continuous improvement through CAPA effectiveness, nonconformance management, and systemic problem solving.
  • Foster organizational capability through coaching, mentoring, and development of high-performing teams.

Skills

Quality Engineering Leadership
Regulatory Compliance
Risk Management
Cross-functional Collaboration
Data-driven Decision Making

Education

Bachelor's degree in a technical discipline

Tools

Quality Management Systems (QMS)
Design Controls
CAPA & Corrective Action

Job description

Dexcom is seeking a Senior Manager, QA Engineering to lead a team responsible for the development, qualification, validation, and deployment of high-volume manufacturing automation equipment. You will ensure regulatory compliance and drive quality across product lifecycles.

You will collaborate with Engineering, Operations, and R&D to mitigate risks, improve CAPA processes, and advance quality metrics, with a strong emphasis on scalable, compliant manufacturing and continuous improvement.

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