Director, SW Quality – Consumer Applications

🕒 2 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $164.200 - $273.600 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Dexcom

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1999

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Dexcom é um dos principais fornecedores de sistemas de monitoramento contínuo de glicose (CGM), revolucionando como as pessoas gerenciam o diabetes e acompanham seus níveis de glicose. Conhecida por sua tecnologia de biossensores de glicose de alta qualidade, a Dexcom oferece produtos como o sistema Dexcom G7 CGM, que fornece monitoramento de glicose em tempo real e insights para ajudar os indivíduos a se tornarem mais saudáveis. Fundada em 1999, a Dexcom tem inovado consistentemente no campo do gerenciamento de diabetes, capacitando os usuários a tomarem controle de sua saúde com soluções precisas e avançadas de monitoramento de glicose. Seus produtos são projetados tanto para adultos quanto para crianças e não exigem receita médica.

Descrição

• 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

🎯 Requisitos

• 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%

🏖️ Benefícios

• 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