Senior QA Engineer: CGM Quality & Compliance Lead

Dexcom; San Diego (CA); On-site; USD 87,000 - 145,000; Full time

Benefits offered by this job

Comprehensive benefits

Growth opportunities

Career development programs

Job summary

Dexcom in San Diego, CA, is seeking a Senior Quality Engineer to lead complex quality investigations, CAPAs, and risk-based problem solving across cross-functional teams. You will drive QMS excellence and validation strategies for equipment, processes, test methods, and software V&V, ensuring product safety and regulatory compliance.

You will collaborate with R&D, Regulatory Affairs, Manufacturing, Operations, and global teams, guide design transfer, and help scale new products from development

Qualifications

• Bachelor's degree in a technical discipline with experience in regulated manufacturing.
• Advanced quality engineering knowledge in risk management, Six Sigma, Cpk/Ppk, and statistical analysis.
• Experience developing and executing validation strategies (IQ/OQ/PQ/PV) and software V&V.
• Cross-functional leadership across Engineering, Operations, R&D and Regulatory.

Responsibilities

• Lead complex quality investigations and CAPAs to improve product quality and compliance.
• Provide technical leadership in quality engineering and process validation.
• Own validation/qualification strategies for equipment, processes, test methods, and software V&V.
• Represent Quality in internal audits and regulatory inspections.

Skills

Quality engineering

Six Sigma

Risk management

FMEA

CAPA

Gage R&R

Validation IQ/OQ/PQ/PV

Software V&V

Data analysis (Excel/JMP)

Education

Bachelor's degree in a technical discipline

Tools

JMP

Excel

Job description

Dexcom in San Diego, CA, is seeking a Senior Quality Engineer to lead complex quality investigations, CAPAs, and risk-based problem solving across cross-functional teams. You will drive QMS excellence and validation strategies for equipment, processes, test methods, and software V&V, ensuring product safety and regulatory compliance.

You will collaborate with R&D, Regulatory Affairs, Manufacturing, Operations, and global teams, guide design transfer, and help scale new products from development