Senior Software QA

Job Overview:

Lead Software quality for next-generation medical devices as a Senior Quality Engineer (Remote) and help deliver life-changing innovations to patients!

The Opportunity:

• Drive software/firmware quality as a technical leader throughout product development, owning risk management, design controls, requirements, and verification/validation activities.
• Perform code reviews at the application level-code written in C++ or C#.
• Chair the change control board for projects, steering defect and change resolution.
• Be the resident expert during code reviews, software/firmware complaint investigations, audit responses, CAPAs, and regulatory audits.
• Maintain top-notch documentation for risk management, compliance, and software validation.
• Collaborate with R&D, Clinical, Regulatory, and Operations to ensure designs meet rigorous standards and compliance across IEC 62304, ISO 13485, 21 CFR Part 820, and more.

Experience/Expertise required:

• BS in Computer Engineering, Computer Science, Electrical Engineering, or related field.
• 5+ years’ quality engineering in medical software/firmware; implantable device experience is a big plus.
• Demonstrated leadership in quality engineering, with clear communication and organization.
• Deep knowledge of medical device regulations and software standards.

Join a passionate team advancing medical breakthroughs! Apply now to shape the future of healthcare!