Software QA Engineer, Level 2

🕒 4 days ago

🇺🇸 United States – Remote

💵 $78.9k - $131.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

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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

• 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

🎯 Requirements

• 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%

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