[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.
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