Senior Software QA Engineer - Medical Devices

MicroAire Surgical Instruments LLC; Charlottesville (VA); On-site; USD 88,000 - 110,000; Full time

Job summary

MicroAire Surgical Instruments LLC seeks a Senior Software Quality Assurance Engineer to provide independent quality oversight across the software lifecycle for medical devices. You will lead complex QA activities, review requirements and validation, and drive improvements with Engineering, Regulatory Affairs, and Manufacturing.

You will contribute to cybersecurity quality, risk management, and supplier quality oversight, ensuring compliance with FDA and ISO standards while collaborating with

Qualifications

• Bachelor's degree or higher in a related technical field.
• 5+ years of progressive Software Quality Assurance experience in regulated industry.
• Hands-on software development experience and ability to review software deliverables.
• Experience with one or more programming languages, including C++ and embedded software.

Responsibilities

• Provide QA oversight for software development across the product lifecycle.
• Review software requirements, design, verification and validation protocols, and release documentation.
• Lead software risk analyses and cybersecurity quality activities.
• Support regulatory inspections and audits, quality metrics, and CAPA processes.
• Collaborate with engineering, regulatory, and product teams to improve software quality.

Skills

C++ programming

Embedded software

Software Quality Assurance

Quality systems

Education

Bachelor's degree in CS/Software/EE/biomedical engineering

Tools

Azure DevOps

GitHub

GitLab

Jira

Jama

Job description

MicroAire Surgical Instruments LLC seeks a Senior Software Quality Assurance Engineer to provide independent quality oversight across the software lifecycle for medical devices. You will lead complex QA activities, review requirements and validation, and drive improvements with Engineering, Regulatory Affairs, and Manufacturing.

You will contribute to cybersecurity quality, risk management, and supplier quality oversight, ensuring compliance with FDA and ISO standards while collaborating with