Software QA Engineer 1

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They are seeking a Software QA Engineer 1 to provide technical support and guidance to software teams, ensuring compliance with software development processes and quality standards while focusing on product improvement and defect prevention.

Responsibilities:

• 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

Requirements:

• Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
• 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
• Typically requires a bachelor's degree in a technical discipline, and a minimum of 0-2 years of related experience
• ASQ Certified Software Quality Engineer (CSQE)
• Cyber Security experience
• Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously