Medical Device Software Quality Engineer
6 days ago
We are seeking a highly skilled Software Quality Assurance Engineer to join our team at Kyyba. As a key member of our organization, you will be responsible for providing software quality support for new medical device product development.
Main ResponsibilitiesOur ideal candidate will have a strong background in software quality engineering and experience with FDA design controls, software verification/validation, and risk analysis. Key responsibilities will include:
- Providing software quality support for new medical device product development
- Ensuring compliance with FDA design controls and software development lifecycle (SDLC) requirements
- Developing and implementing software verification/validation plans and procedures
- Conducting risk analysis and defect reporting
- Managing software configuration management
To be successful in this role, you will need:
- A BS degree in engineering, technical field, or equivalent
- At least 5 years of experience in medical device software development lifecycle (SDLC), FDA design controls, software quality engineering, and software verification/validation
- Strong knowledge of ISO Medical Device QMS and ISO Medical Device Risk Management
- Excellent communication and problem-solving skills
At Kyyba, we offer a dynamic and supportive work environment, competitive compensation, and opportunities for career growth and development. If you are a motivated and detail-oriented individual with a passion for software quality engineering, we encourage you to apply for this exciting opportunity.
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Irving, Texas, United States KYYBA Full timeJob OverviewWe are seeking a highly skilled Software Quality Assurance Engineer to join our team at Kyyba. As a key member of our organization, you will be responsible for providing software quality support for new medical device product development.Main ResponsibilitiesOur ideal candidate will have a strong background in software quality engineering and...
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