Senior Software QA Engineer – Medical Devices

Dexcom; California (MO); On-site; USD 79,000 - 132,000; Full time

Benefits offered by this job

Competitive benefits

Growth opportunities

Job summary

Dexcom is seeking a Software Quality Assurance Engineer to join the R&D Quality Assurance Engineering team. You will guide compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971 across software groups, support risk management, and drive verification, documentation, and post-market activities.

You’ll collaborate with cross-functional teams and management to maintain quality and continuous improvement. The role emphasizes SDLC, agile methods, and strong communication.

Qualifications

• - Experience with software mobile applications.
• - Medical device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971.
• - Knowledge of SDLC processes and Agile/Waterfall.
• - 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 testing experience.
• - Drive projects to completion with limited supervision.
• - Ability to communicate with all levels of management.
• - Nice to have knowledge of Cyber Security.
• - Nice to have CSQE certification or equivalent.
• - Nice to have Jama, Jira, Kettryx, and/or TestRail experience.

Responsibilities

• - Act as core team member of the R&D Quality Assurance Engineering team.
• - Provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other regulations to cross-functional teams.
• - Lead effective application, compliance, and improvement of policies related to software development and validation.
• - Provide technical guidance on equipment, software, product, and process requirements; drive risk management deliverables.
• - Guide Software Design and Test Teams for system validations, design verification, and traceability.
• - Support post-market activities related to software anomalies, risk assessments and CAPA.
• - Review and author technical documentation including DHF, SOPs, protocols, reports, and software design control deliverables.
• - Assess change control impact to maintain compliance and product performance.
• - Communicate plans and progress with the Dexcom team and management.
• - Assume other duties as assigned.

Skills

Software QA

Regulatory compliance

SDLC

Agile

Risk management

Documentation

Software testing

Communication

Cyber Security

CSQE

Jama

Jira

Kettryx

TestRail

Education

Bachelor's degree in a technical discipline

Tools

Jama

Jira

Kettryx

TestRail

Job description

Dexcom is seeking a Software Quality Assurance Engineer to join the R&D Quality Assurance Engineering team. You will guide compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971 across software groups, support risk management, and drive verification, documentation, and post-market activities.

You’ll collaborate with cross-functional teams and management to maintain quality and continuous improvement. The role emphasizes SDLC, agile methods, and strong communication.