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Software Quality Assurance Engineer
2 months ago
Sensus Healthcare is seeking a highly skilled Software Quality Assurance Engineer to join our team. As a Software Quality Assurance Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.
Key Responsibilities- Regulatory Compliance: Ensure that our software development processes and products comply with regulatory requirements such as ISO 13485:2016, FDA's regulations (e.g., 21 CFR Part 820), EU MDR, and MDSAP regulations.
- Quality Assurance: Design and implement quality assurance processes to ensure that our software meets the required quality standards. This includes creating test plans, conducting testing, and ensuring that software defects are identified and addressed.
- Risk Management: Identify and mitigate risks associated with our software to ensure patient safety.
- Documentation: Create and maintain documentation related to software development processes, testing procedures, and quality assurance activities.
- Collaboration: Work closely with software developers, quality assurance and operations teams, regulatory affairs professionals, and other stakeholders to ensure that software development processes meet regulatory requirements and quality standards.
- Continuous Improvement: Identify opportunities for process improvement and implement best practices to enhance software quality.
- Minimum of Associate or BS degree in Computer Science, Software, Electronics, or Electrical Engineering or Equivalent
- Experience following code execution paths
- Experience with OOP architecture
- Strong knowledge of the software development life cycle
- Experience with code repositories (Git preferred)
- Knowledge of ISO 13485:2016, FDA's regulations (e.g., 21 CFR Part 820), knowledge of EU MDR, MDSAP regulations a plus
- Understanding Java, C++, NodeJs, JavaScript
- Ability to follow the code
- MySQL databases
- UML diagrams
- Experience with Jira
