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Empowering people to take control of health
Software QA Engineer
Location
Oregon
Posted
108 days ago
Salary
$61.9K - $103.1K / year
Seniority
Mid Level
Job Description
Software QA Engineer
Dexcom
• Actively participates as a core team member of the R&D Quality Assurance Engineering team. • Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide. • Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including: Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management. • Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations. • Reviews and approves all software design control deliverables. • Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable). • Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes. • Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc. • Assesses the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained. • Effectively communicates with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges. • Assumes and performs other duties as assigned.
Job Requirements
- Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
- Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
- Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
- Ability to interpret software design and code to verify implementation of requirements
- Software development and/or Software test experience
- Ability to communicate and present to all levels of management.
- Ability to understand complex tasks and goals.
- Drive projects to completion with limited supervision.
- Experience working with cloud-based systems.
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.
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