Director, Global Design Control & Risk Management

RXinsider LTD.; Northern, San Diego (KY, CA); Hybrid; USD 164,000 - 274,000; Full time

Benefits offered by this job

CGM technology impact

Benefits program

Global growth opportunities

Career development

Innovative organization

Job summary

Dexcom is seeking a global leader to own Design Control and Risk Management quality system processes across the product lifecycle. You will drive end-to-end traceability, lead training, and collaborate with cross-functional teams for regulatory readiness.

This senior role requires 13+ years in medical device development and 8+ years in leadership, with an engineering background. You’ll promote cross-functional quality standards, engage in audits, and guide the organization through CAPA and

Qualifications

• Global Design Control process leadership experience.
• Global Risk Management process leadership (ISO 14971 and IEC 60812).
• Risk Management integrated into Quality Management Systems (FDA QMSR and ISO 13485).

Responsibilities

• Owns design control and risk management procedures across product lifecycle.
• Develops training programs and drives continuous improvement.
• Represents Design Control and Risk Management during regulatory audits.

Skills

Design Control

Risk Management

Regulatory Inspections

Leadership

Education

Bachelor’s degree in a technical discipline

Engineering degree preferred

Tools

Quality Management IT systems

Job description

Dexcom is seeking a global leader to own Design Control and Risk Management quality system processes across the product lifecycle. You will drive end-to-end traceability, lead training, and collaborate with cross-functional teams for regulatory readiness.

This senior role requires 13+ years in medical device development and 8+ years in leadership, with an engineering background. You’ll promote cross-functional quality standards, engage in audits, and guide the organization through CAPA and