Koning Corporation
Software QA Engineer
Norcross, GA | $60K - $70K
Qualifications
- Bachelor's degree in Computer Science, Software Engineering, or related field
- Proven experience in software quality assurance, particularly in the development of Class III medical devices
- Familiarity with FDA regulations and software development process specifications
- Strong analytical and problem-solving skills
- Excellent communication and documentation abilities
- Detail-oriented with a commitment to maintaining high-quality standards
- Norcross, GA: Relocate before starting work (Required)
Responsibilities
- Ensure Compliance: Ensure the integrity and compliance of the company's software development process in accordance with FDA requirements for the development and management of Class III medical devices
- FDA Implementation: Implement FDA requirements for software development process specifications, conducting organized reviews and risk analyses at all stages of software development
- Document Management: Manage development documents, including development plans, requirements specifications, design specifications, test reports, system risk analysis, user manuals, and installation instructions
- FDA Submission: Prepare software materials for FDA submission, ensuring accuracy and completeness in alignment with regulatory guidelines
- System Requirements and Test Plans: Manage system requirements and design comprehensive test plans based on product specifications
- Develop test data and cases to ensure thorough testing coverage
- Optimization and Improvement: Collect suggestions for system function optimization and performance improvement, organize work items, and manage system requirements after thorough discussion and review
- Test Planning and Review: Write test plans based on system requirements specifications, prepare test environments, test data, and conduct reviews for comprehensive coverage
- Organize test plans and test case reviews
- Software Testing: Perform unit/functional testing and performance testing of the pre-release system according to the test plan and use cases
- Create test scripts to meet testing needs
- Integration and Regression Testing: Conduct system integration testing, regression testing, and other relevant tests to ensure the robustness and reliability of the software
- Bug Management: Manage software bugs effectively, ensuring timely identification, documentation, and resolution
- Test Reporting: Generate, organize, and archive detailed test reports, providing clear insights into the testing process and results
- Other Responsibilities: Assist with general QMS management for software protocols
- Assist with on-site and remote audits, facilitating documents and elaborating on software protocols to ensure adherence to regulatory standards
Benefits
- Pay: $60,000.00 - $70,000.00 per year
- Dental insurance
- Health insurance
- Paid time off
- Compensation package:
- Stock options
- 8 hour shift
- 11-50 employees
- Manufacturing, Construction, Technology, Engineering, Renewable Energy
- Privately Held
- Last round: Sep 1, 2022
- Last round: US$ 103.9K
- Norcross, GA
- Company Specialties:
Breast cancer detection, 3D Computed tomography, Medical devices, Medical imaging, and Breast cancer
Company information
Koning Corporation develops and manufactures advanced medical imaging systems for breast cancer detection using cone-beam computed tomography technology. This revolutionary technology provides true 3D images for early breast cancer detection, providing a significantly more accurate and effective test than mammography and tomosynthesis. Koning's vision is to fundamentally change breast cancer is detected and diagnosed, with earlier detection, increased patient comfort and lower costs. We believe our Koning Breast CT will dramatically improve the way clinicians visualize and evaluate breast tissue. We believe that the power, versatility and lower cost of Koning Breast CT will serve as a viable substitute for many traditional imaging applications. Our hope is to be able to improve survival rates and outcomes for millions of patients. Koning Corporation's core technologies are protected by over 80 patents globally, and has received regulatory approval in the US (FDA), Europe (CE-Mark), China (CFDA), Australia (TPG), and Canada (Health Canada). Koning has been the beneficiary of over $17 M in venture funding and over $20 M in government grants to bring this exciting technology to market. Future versions of our technology are expected to optimize early disease detection, diagnosis, intervention and treatment in numerous areas of the body.
