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Software Quality Assurance Engineer
2 months ago
About Us
Sensus Healthcare stands at the forefront of manufacturing advanced superficial radiotherapy devices, recognized by the FDA for their efficacy in treating non-melanoma skin cancers and keloids. Our innovative product line includes the SRT-100TM, SRT-100+TM, and SRT-100 VisionTM, all utilizing proprietary low-energy X-ray technology developed through extensive research and development efforts. With over 700 devices in operation across the United States and more than 100 internationally, our solutions are primarily utilized in dermatology and plastic surgery, with an expanding presence in Radiation Oncology.
Position Overview
We are seeking a dedicated Software Quality Assurance Engineer to join our team, reporting directly to the Director of Quality Assurance and Regulatory Affairs. This role within a medical device organization is both challenging and rewarding, demanding meticulous attention to detail, a solid grasp of regulatory standards, and a steadfast commitment to maintaining the quality and safety of software utilized in medical devices.
Key Responsibilities:
Regulatory Adherence:
In the medical device sector, compliance with stringent regulatory standards such as ISO 13485:2016, FDA regulations (e.g., 21 CFR Part 820), EU MDR, and MDSAP is critical. As a Software Quality Assurance Engineer, you will ensure that software development processes and products align with these regulations.
Quality Control:
Your responsibilities will include the design and implementation of quality control processes to guarantee that the software developed for medical devices meets established quality benchmarks. This encompasses the creation of test plans, execution of testing protocols, and the identification and resolution of software defects.
Risk Assessment:
Risk management is vital in the medical device field. You will play a key role in identifying and mitigating risks associated with the software used in medical devices, ensuring the safety of patients.
Documentation Management:
Maintaining comprehensive documentation is essential for quality assurance in the medical device industry. You will be tasked with creating and upholding documentation related to software development processes, testing methodologies, and quality assurance activities.
Team Collaboration:
As a Software Quality Assurance Engineer, you will collaborate closely with software developers, leading software verification and validation efforts, and engaging with quality assurance teams, regulatory affairs professionals, and other stakeholders to ensure compliance with regulatory standards and quality expectations.
Continuous Development:
Continuous improvement is a cornerstone of the medical device industry, aimed at enhancing product quality and adhering to evolving regulations. You will be involved in identifying process improvement opportunities and implementing best practices to elevate software quality.
Accountability:
Working in the medical device industry entails a significant level of responsibility due to the critical nature of the products developed. Ensuring the quality and safety of software utilized in medical devices is of utmost importance, and as a Software Quality Assurance Engineer, you will be integral to this mission.
Qualifications:
- Associate or Bachelor's degree in Computer Science, Software Engineering, Electronics, Electrical Engineering, or a related field
- Experience in following code execution paths
- Familiarity with Object-Oriented Programming (OOP) architecture
- Strong understanding of the software development lifecycle
- Experience with code repositories (preferably Git)
- Knowledge of ISO 13485:2016, FDA regulations (e.g., 21 CFR Part 820), and familiarity with EU MDR and MDSAP regulations is advantageous
Experience in Software Verification and Validation, as well as Software Quality Assurance Testing, is required.
Preferred Skills:
- Proficiency in Java, C++, NodeJs, and JavaScript
- Ability to trace code execution
- Experience with MySQL databases
- Familiarity with UML diagrams
Experience with project management tools such as Jira is beneficial.
Benefits:
We offer a comprehensive benefits package including Paid Time Off, Medical/Dental Insurance, and a 401(k) plan.
