Software QA Engineer 2

Job not on LinkedIn

3 days ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🌲 Oregon – Remote

Although this job is listed in Oregon, this company may be open to hiring remote in other states.

💵 $75.2k - $125.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

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Dexcom

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Healthcare Insurance • Biotechnology • Wearable Technology

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.

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Actively 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 relevant regulations worldwide to cross-functional teams. • Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams. • Provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA. • Provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations. • Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable). • Responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables. • Assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained. • Effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges. • Assume and perform other duties as assigned.

🎯 Requirements

• Experience working with software mobile applications. • Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971. • Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model. • Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test. • Proficiency to interpret software design and code to verify implementation of requirements. • Software development and/or Software test experience. • Ability to understand complex tasks and goals. • Ability to communicate and present to all levels of management. • Nice to have knowledge of Cyber Security. • Nice to have ASQ Certified Software Quality Engineer (CSQE) certification or equivalent.

🏖️ Benefits

• A front row seat to life changing CGM technology. • Learn about our brave #dexcomwarriors community. • A full and comprehensive benefits program. • Growth opportunities on a global scale. • Access to career development through in-house learning programs and/or qualified tuition reimbursement. • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.