Director, SW Quality – Consumer Applications

Dexcom

Director leading software quality engineering for Dexcom’s consumer CGM applications and data platforms. Ensuring regulated development, testing, risk management, and releases across digital health products.

Posted 8/4/2026full-timeRemote • 🇺🇸 United StatesLead💰 $164,200 - $273,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Software Quality Assurance, regulatory compliance, and risk management within the medical device industry. Proficient in leading teams, managing software development life cycles, and ensuring adherence to quality standards and regulations.

Highest-signal resume keywords

FDA 21 CFR Part 820 Quality System RegulationFDA 21 CFR Part 11 Electronic Records and Electronic SignaturesSDLC GxP ToolsIEC 62304 ComplianceISO 14971 Risk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Quality AssuranceRisk ManagementRegulatory ComplianceAutomated Testing MethodologiesSoftware ValidationGxP ValidationConfiguration ManagementDefect ManagementProject ManagementDigital Health

Soft Skills

LeadershipCoachingCross-Functional CollaborationStrategic PlanningCommunication

Tools & Technologies

ALMElectronic ALM SystemsClinical Decision Support ToolsIoT EnvironmentsGAMP

Industry Keywords

Software as a Medical DeviceMedical Device SoftwareCybersecurity GuidanceRegulatory Agency AuditsPDP Compliance

Tech Stack

Tools & technologies

Cyber SecurityIoTSDLC

About the role

Key responsibilities & impact

Manage the Software Quality Assurance Consumer Applications and Data Platform Solution teams
Define priorities and delegate responsibilities
Use customer and consumer feedback to drive continuous improvement aligned with strategic goals
Promote cross-functional understanding and adherence to quality and regulatory standards
Establish and report key software development metrics
Coach and guide teams on project plans, requirements, design, and test cases
Create risk-based lightweight SDLCs for Class I/II exempt applications and components
Partner with R&D to ensure development and testing processes comply with current regulations
Identify compliance gaps and update relevant procedures with departmental support
Lead risk management activities and mitigation strategy discussions
Ensure the team is prepared for regulatory agency audits
Provide leadership in the Design/Phase Review process to ensure PDP compliance
Coordinate, manage, and track team efforts to meet milestones within budgets and schedules

Requirements

What you’ll need

Bachelor’s degree in a technical discipline
15+ years of industry experience
9+ years of successful management experience in a relevant industry
Expertise or strong working knowledge of FDA 21 CFR Part 820 Quality System Regulation
Expertise or strong working knowledge of FDA 21 CFR Part 11 Electronic Records and Electronic Signatures
Expertise or strong working knowledge of SDLC GxP tools, including ALM for software, configuration management, and defect management
Deep understanding of IEC 62304 compliance
Knowledge of Software as a Medical Device, software in medical device product IoT environments, digital health, and clinical decision support tools
Knowledge of automated testing methodologies
Knowledge of FDA software validation and medical-device software premarket and cybersecurity guidance
Knowledge of ISO 14971 risk management for medical devices
Knowledge of GxP validation and GAMP
Knowledge of FDA Computer Software Assurance
Knowledge of electronic ALM systems for requirements, risk, test, defect, and configuration management
Ability to travel 10–15%

Benefits

Comp & perks

A full and comprehensive benefits program
Growth opportunities on a global scale
Career development through in-house learning programs and/or qualified tuition reimbursement
Home office workplace
Flex workplace option may be available
Front-row access to life-changing CGM technology
Innovative, industry-leading organization committed to employees, customers, and communities