We are seeking an experienced Senior QA Engineer with strong expertise in manual testing and a solid background in the healthcare and medical imaging domain. The ideal candidate will have a deep understanding of DICOM standards, annotations, clinical workflows, and hospital information systems, along with hands-on experience in verification and validation (V&V) processes for regulated environments. This role requires strong analytical skills, meticulous attention to detail, and the ability to ensure compliance with healthcare standards and regulatory requirements.
Key Responsibilities:
- Plan, design, and execute manual test cases for healthcare software and systems.
- Perform system testing, integration testing, and V&V (Verification & Validation) in compliance with medical device regulations.
- Validate and test DICOM workflows, medical imaging annotations, and data interoperability between devices and healthcare systems.
- Conduct hardware setup and configuration testing to ensure seamless integration of software and equipment.
- Work closely with product, development, and clinical teams to validate system behavior against healthcare standards.
- Review and interpret clinical data, ensuring test coverage across real-world use cases.
- Identify, log, and track defects using standard defect management tools, providing clear documentation with logs and screenshots.
- Ensure adherence to FDA, HIPAA, and other relevant compliance standards in testing and documentation.
- Collaborate with cross-functional teams to enhance quality processes and drive continuous improvement.
- Provide domain guidance and mentor junior QA engineers within the team.
Required Skills and Qualifications:
- 10+ years of hands-on experience in Manual Testing.
- 6+ years of experience in the Healthcare/Medical Imaging domain.
- Strong understanding of DICOM, annotations, and medical imaging workflows.
- Sound knowledge of Verification & Validation (V&V) processes, system testing, and regulatory compliance (FDA, HIPAA preferred).
- Experience in hardware setup and configuration testing.
- Understanding of hospital workflows, including patient journey, EMR/EHR, HL7, and HIS/LIS/RIS systems.
- Strong analytical, problem-solving, and troubleshooting skills.
- Excellent verbal and written communication skills with the ability to present findings effectively.
- Clinical experience or background in a healthcare environment is highly desirable.
