[Remote] Software QA Engineer 1

Note: The job is a remote job and is open to candidates in USA. Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), focusing on improving human health through innovative technology. The Software QA Engineer 1 will provide technical support to ensure compliance with software development processes and quality standards, while collaborating with various cross-functional teams to enhance product development 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

Skills

• Typically requires a bachelor's degree in a technical discipline
• Minimum of 0-2 years of related experience
• 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
• 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
• 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
• 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

Benefits

• 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.

Company Overview

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