Software QA Engineer, Level 2

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as an essential member of the R&D Quality Assurance Engineering team.

• Offer expertise on IEC 62304, 21 CFR 820, ISO 14971, and various international standards to cross-functional teams.

• Oversee the implementation, adherence, and ongoing enhancement of software development and validation policies and practices.

• Provide technical expertise regarding equipment, software, product, and process specifications.

• Lead risk management tasks including SHA and design and process FMEA.

• Advise Software Design and Test Teams on system validations, software design verification and traceability, configuration management, tool validations, and software integrations.

• Assist with post-market activities concerning software anomalies, risk assessments, and CAPA.

• Review, create, revise, and approve technical documentation such as design history files, SOPs, protocols, reports, and software design control deliverables.

• Evaluate change-control impacts to ensure product performance and compliance.

• Communicate plans, task status, project updates, and challenges to Dexcom teams and senior management.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor's degree in a technical field with 2–5 years of relevant experience, or a Master's degree with 0–2 years of equivalent experience.

• Experience with software mobile applications.

• Background in medical devices adhering to FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.

• Familiarity and experience with SDLC processes and Agile or Waterfall software development methodologies.

• Software quality or engineering experience in requirements analysis, design/development, product integration, and testing.

• Ability to interpret software design and code to validate requirements implementation.

• Experience in software development and/or software testing.

• Capability to comprehend complex tasks and objectives and drive projects to completion with minimal supervision.

• Strong communication skills to present information to all management levels.

• Cybersecurity knowledge is preferred.

• ASQ Certified Software Quality Engineer (CSQE) certification or equivalent is preferred.

• Experience with Jama, Jira, Kettryx, and/or TestRail is preferred.

• Willingness to travel up to 5%.

🏝️ Benefits

• A comprehensive and inclusive benefits program.

• Global growth opportunities.

• Career advancement through internal learning programs and/or eligible tuition reimbursement.

• An innovative organization at the forefront of the industry, dedicated to employees, customers, and communities.