Director, SW Quality – Consumer Applications

Job not on LinkedIn

🔥 17 minutes ago

🇺🇸 United States – Remote

💵 $164.2k - $273.6k / year

⏰ Full Time

🔴 Lead

👔 Director

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• 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

• 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

• 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