Global QA & Design Control Leader (Medical Devices)

Dexcom; San Diego (CA); On-site; USD 164,000 - 274,000; Full time

Benefits offered by this job

Comprehensive benefits

Career growth opportunities

Tuition reimbursement

Global opportunities

Job summary

Dexcom seeks a seasoned Quality Leadership professional to own Design Control and Risk Management across our product life cycle. You will establish end-to-end traceability, drive training, and lead regulatory readiness with audits. The role requires 13+ years in medical device development and 8+ years in leadership, with an engineering degree preferred.

The primary work location is a home office with occasional site visits; remote work within the U.S. is supported and travelers may be required.

Qualifications

• Typically requires a Bachelor's degree with 15+ years of industry experience.
• Requires a degree in a technical discipline
• 9+ years of successful management experience in relevant industry

Responsibilities

• Owns all Design Control and Risk Management procedures, instructions, templates, and tools.
• Develops and drives training programs for organizational execution.
• Promotes cross-functional adherence to quality standards and regulatory requirements.
• Represents Design Control and Risk Management during regulatory audits and inquiries.
• Leads, organizes, develops, and grows an organization of site Business Process Owners.

Skills

Global Design Control leadership

Global Risk Management leadership

Quality Management Systems

Training program development

CAPA and quality improvements

Regulatory audits & inspections

People leadership

Communication skills

Engineering degree preferred

Education

Bachelor's degree in technical discipline

Engineering degree preferred

Job description

Dexcom seeks a seasoned Quality Leadership professional to own Design Control and Risk Management across our product life cycle. You will establish end-to-end traceability, drive training, and lead regulatory readiness with audits. The role requires 13+ years in medical device development and 8+ years in leadership, with an engineering degree preferred.

The primary work location is a home office with occasional site visits; remote work within the U.S. is supported and travelers may be required.