Software QA Engineer II - Medical Devices Compliance

Dexcom, Inc; San Diego (CA); On-site; USD 79,000 - 132,000; Full time

Benefits offered by this job

Benefits program

Job summary

Dexcom is seeking a qualified R&D Quality Assurance Engineer to join the software-focused QA team. The role provides guidance on IEC 62304, 21 CFR 820, ISO 14971 and related worldwide regulations to cross-functional groups and drives continuous improvement of software development and validation practices.

You will support risk assessments, CAPA activities, design history files, SOPs, and verification activities, collaborating with Software Design, Test, Regulatory Affairs, and Project management

Qualifications

• Experience with software mobile applications.
• Medical device experience in FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971.
• Knowledge of SDLC and methodologies such as Agile and Waterfall.
• Experience in Requirements Analysis, Design/Development, Product Integration and Test.
• Ability to interpret software design and code to verify requirements.
• Experience in software development and/or software testing.
• Ability to communicate and present to all management levels.

Responsibilities

• Participate as core team member of the R&D Quality Assurance Engineering team.
• Lead application, compliance, and continuous improvement of policies and procedures for software development and validation.
• Provide guidance on device and software requirements and driving risk management deliverables.
• Support system validations, design verifications and traceability, configuration management, and tool validations.
• Communicate plans, status, and challenges to Dexcom management.
• Perform other duties as assigned.

Skills

Software quality

Regulatory requirements

Communication

Project management

Education

Bachelor’s degree in technical discipline

Tools

Jama

Jira

Kettryx

TestRails

Job description

Dexcom is seeking a qualified R&D Quality Assurance Engineer to join the software-focused QA team. The role provides guidance on IEC 62304, 21 CFR 820, ISO 14971 and related worldwide regulations to cross-functional groups and drives continuous improvement of software development and validation practices.

You will support risk assessments, CAPA activities, design history files, SOPs, and verification activities, collaborating with Software Design, Test, Regulatory Affairs, and Project management