Software QA Engineer, Level 2

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $78.900 - $131.500 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🔧 Engenheiro de QA (Qualidade de Software)

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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

• Participate as a core team member of the R&D Quality Assurance Engineering team • Provide guidance on IEC 62304, 21 CFR 820, ISO 14971, and other worldwide regulations to cross-functional teams • Lead application, compliance, and continuous improvement of software development and validation policies and practices • Provide technical guidance on equipment, software, product, and process requirements • Drive risk management deliverables including SHA and design and process FMEA • Guide Software Design and Test Teams on system validations, software design verification and traceability, configuration management, tool validations, and software integrations • Support post-market activities related to software anomalies, risk assessments, and CAPA • Review, author, revise, and approve technical documentation, including design history files, SOPs, protocols, reports, and software design control deliverables • Assess change-control impact to maintain product performance and compliance • Communicate plans, task status, project progress, and challenges to Dexcom teams and upper-level management • Perform other duties as assigned

🎯 Requisitos

• Bachelor's degree in a technical discipline and 2–5 years of related experience, or Master's degree and 0–2 years' equivalent experience • Experience working with software mobile applications • Medical device experience complying with FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971 • Knowledge and experience with SDLC processes and Agile or Waterfall software development methodologies • Software quality or engineering experience in requirements analysis, design/development, product integration, and testing • Proficiency interpreting software design and code to verify requirements implementation • Software development and/or software test experience • Ability to understand complex tasks and goals and drive projects to completion with limited supervision • Ability to communicate and present to all levels of management • Cybersecurity knowledge preferred • ASQ Certified Software Quality Engineer (CSQE) certification or equivalent preferred • Jama, Jira, Kettryx, and/or TestRail experience preferred • Travel requirement of 0–5%

🏖️ 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 • Innovative, industry-leading organization committed to employees, customers, and communities