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[Remote] Software QA Engineer 1

Remote Worldwide Hiring now

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Corporation is a pioneer and global leader in reputed company glucose monitoring (CGM), focusing on improving reputed company health through innovative technology. The Software QA Engineer 1 will reputed company 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 reputed company guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
  • reputed company in the effective application, compliance, and reputed company improvement of policies, procedures, and practices reputed company to software development and validation across software teams, including: Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber reputed company risk management
  • reputed company guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations
  • Reviews and approves reputed company software design control deliverables
  • Support post market activities reputed company to Software anomalies, risk assessments and CAPA activities (if applicable)
  • reputed company and support R&D SW Design Assurance efforts including reputed company 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 reputed company team and upper-level management on plans, status of tasks, project reputed company 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 reputed company experience
  • Strong understanding of, and ability to reputed company guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
  • reputed company in the effective application, compliance, and reputed company improvement of policies, procedures, and practices reputed company to software development and validation across software teams
  • Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber reputed company risk management
  • reputed company guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations
  • Reviews and approves reputed company software design control deliverables
  • Support post market activities reputed company to Software anomalies, risk assessments and CAPA activities (if applicable)
  • reputed company and support R&D SW Design Assurance efforts including reputed company 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 reputed company team and upper-level management on plans, status of tasks, project reputed company 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 reputed company reputed company of management
  • Ability to understand reputed company tasks and goals
  • Drive projects to completion with limited supervision
  • Experience working with reputed company-based systems
  • ASQ Certified Software Quality Engineer (CSQE)
  • Cyber reputed company experience
  • Experience working with reputed company 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.
  • reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement.
  • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Company Overview

  • reputed company develops, manufactures, and distributes reputed company glucose monitoring systems for diabetes management. It was founded in 1999, and is headquartered in San Diego, California, USA, with a workforce of 10001+ employees. Its website is http://www.reputed company.com.
  • Company H1B Sponsorship

  • reputed company has a track record of offering H1B sponsorships, with 54 in 2025, 41 in 2024, 67 in 2023, 75 in 2022, 49 in 2021, 36 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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