Job Title: Quality Assurance Specialist - Digital Health (SaMD Focus)
About Us:
We are a dynamic and rapidly growing Digital Health company specializing in Software as a Medical Device (SaMD). Our mission is to innovate and provide cutting-edge healthcare solutions that improve patient outcomes. As we continue to expand, we are looking for a passionate and experienced Quality Assurance (QA) Specialist to join our team and contribute to the development of next-generation SaMD products.
The Role:
We are seeking a skilled Quality Assurance Specialist with specific experience in Software as a Medical Device (SaMD) to ensure the highest standards of quality in our digital health products. In this role, you will be responsible for implementing and overseeing quality assurance processes, ensuring regulatory compliance, and contributing to the overall success of our products in the market.
Key Responsibilities:
- Develop and execute comprehensive test plans for SaMD products, ensuring they meet both regulatory and functional requirements.
- Conduct manual and automated testing to verify product functionality, usability, and performance.
- Work closely with cross-functional teams (engineering, product, clinical) to define testing scope, requirements, and timelines.
- Ensure compliance with FDA, CE, ISO 13485, IEC 62304, and other relevant regulatory standards for medical devices.
- Identify, track, and manage defects, collaborating with development teams to resolve issues in a timely manner.
- Maintain and improve quality assurance processes and documentation, ensuring consistency and adherence to best practices.
Required Qualifications:
- Proven experience working with Software as a Medical Device (SaMD) products in a Quality Assurance role.
- Strong understanding of medical device regulatory standards (FDA, CE, ISO 13485, IEC 62304).
- Hands-on experience in manual and automated testing methodologies for SaMD products.
- Familiarity with risk management processes and tools (e.g., FMEA, DFMEA).
- Excellent analytical, troubleshooting, and problem-solving skills.
