Test Manager - Healthcare and Medical Software Domain_Bangaloe

Test Manager Healthcare and Medical Software Domain

We are seeking a highly skilled and experienced Test Manager with 6 to 10 years of experience in the Healthcare and Medical Software domain. The ideal candidate will have a strong background in software quality assurance, an in-depth understanding of regulatory requirements (e.g., FDA, ISO 13485), and a proven track record of managing testing activities for complex healthcare or medical software systems. This role will focus on ensuring product quality, compliance, and reliability through efficient testing strategies and team leadership.

Job Responsibilities:

1. Test Strategy and Planning:

• Develop and implement comprehensive test strategies and plans aligned with regulatory and business requirements.
• Define test objectives, scope, approach, and deliverables for healthcare and medical software projects.
• Plan and manage testing schedules, resource allocation, and budgets.

2. Leadership and Team Management:

• Lead and mentor a cross-functional testing team, fostering a culture of quality and continuous improvement.
• Ensure the team is well-versed in industry standards and best practices in healthcare and medical software testing.
• Coordinate with development, product management, and regulatory teams to ensure seamless communication and collaboration.

3. API Testing:

• Oversee API testing to ensure functionality, performance, and reliability.
• Provide guidance on using tools like Postman for validating API endpoints and ensuring data accuracy.
• Drive the development and execution of API test strategies for RESTful and SOAP APIs.

4. Quality Assurance and Compliance:

• Ensure testing processes comply with industry regulations such as FDA 21 CFR Part 11, IEC 62304, and ISO 13485.
• Collaborate with regulatory teams to prepare documentation for audits and regulatory submissions.
• Maintain a strong focus on patient safety, data integrity, and system reliability

5. Test Automation:

• Define and implement test automation strategies to enhance testing efficiency and coverage.
• Oversee the development and maintenance of automation scripts frameworks using tools like Selenium, TestComplete, or equivalent.
• Collaborate with the team to automate functional, regression, system, API, and performance testing.

6. AI Testing:

• Oversee testing of AI-based healthcare systems to ensure performance, accuracy, and ethical compliance.
• Validate AI/ML models for robustness, data integrity, and decision accuracy in healthcare applications.
• Ensure compliance with emerging AI regulations and standards in healthcare.

7. Test Execution and Management

• Oversee the execution of manual and automated test cases for functional, performance, usability, and security testing.
• Manage defect tracking and resolution, ensuring root cause analysis and corrective actions.
• Monitor and report on testing progress, quality metrics, and risks to stakeholders.

8. Tool and Technology Integration

• Implement and manage test automation tools, performance testing tools, and test management platforms.
• Integrate AI-driven testing tools into CI/CD pipelines for continuous testing.
• Stay updated on emerging technologies and trends in healthcare software testing.

9. Continuous Improvement

• Analyze testing processes and identify areas for optimization and efficiency.
• Promote the adoption of best practices, including shift-left testing, CI/CD integration, and AI-driven testing approaches.

Qualifications and Requirements

• Educational Background

• • Bachelor s or master s degree in computer science, Information Technology, or related field.
• Experience
• • 6 to 10 years of experience in software testing or quality assurance, with at least 3 years in a leadership or management role.
  • Hands-on experience in testing healthcare or medical software systems, including familiarity with EHR, PACS, DICOM, or medical device software.
  • Proven expertise in API testing using tools like Postman.
  • Strong experience in test automation using frameworks and tools like Selenium, TestComplete, or equivalent.
  • Experience in testing AI/ML systems, validating algorithms, and ensuring compliance with ethical and regulatory standards
• Technical Skills

• • Strong understanding of software testing methodologies and tools.
  • Experience with test automation frameworks (e.g., Selenium, TestComplete) and performance testing tools.
  • Proficiency in test management tools like JIRA, HP ALM, or TestRail.
  • Familiarity with coding and scripting languages for test automation (e.g., Python, Java).
  • Familiarity with CI/CD pipelines and integrating automated tests into development workflows.
  • Knowledge of AI/ML testing frameworks and tools.
• Regulatory Knowledge

• • Comprehensive knowledge of regulatory standards such as FDA 21 CFR Part 11, IEC 62304, ISO 14971, and ISO 13485.
• Soft Skills

• • Excellent leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to manage multiple projects and priorities in a dynamic environment.
• Preferred Qualifications

• ISTQB Advanced Level Certification or equivalent.
• Experience in agile and DevOps environments.
• Knowledge of AI and machine learning applications in healthcare software testing.