Global Design Quality Engineer - Remote & Expansion

Dexcom Inc.; California (MO); Hybrid; USD 111,000 - 185,000; Full time

Job summary

Dexcom Inc. is seeking a Staff Design Quality Engineer (Global Expansions) to drive regulatory compliance and design control across international markets. You will ensure DHFs meet local requirements and act as the main Quality contact for regulatory agencies during global expansions.

The role requires strong cross-functional collaboration, experience in medical device development, and a proven ability to lead CAPA and investigation processes with a proactive, quality-focused mindset.

Qualifications

• Minimum 8+ years in medical device development.
• At least 5+ years leading and implementing global expansions in medical device development.
• Strong collaboration, interpersonal, written and verbal communication skills.
• Experience aligning DHFs with regulatory requirements for international markets.

Responsibilities

• Align DHFs with the compliance requirements of target international markets.
• Lead Quality Lead responsible for assessing impact of change controls, CAPAs, and Non-Conformances on the system.
• Serve as Quality contact for regulatory agencies during global expansions.
• Lead investigations from CAPAs and complaint investigations.
• Identify, prioritize, communicate, and resolve quality issues.

Skills

Design Quality

Regulatory Compliance

CAPA Management

Global Expansions

Cross-functional Collaboration

Education

Bachelor’s degree in technical discipline

Job description

Dexcom Inc. is seeking a Staff Design Quality Engineer (Global Expansions) to drive regulatory compliance and design control across international markets. You will ensure DHFs meet local requirements and act as the main Quality contact for regulatory agencies during global expansions.

The role requires strong cross-functional collaboration, experience in medical device development, and a proven ability to lead CAPA and investigation processes with a proactive, quality-focused mindset.