Katalyst Healthcares and Life Sciences
QA Tester - Medical Devices Testing
Katalyst Healthcares and Life Sciences, Johnstown, Colorado, United States, 80534
Responsibilities and Requirements:
QA Software Tester for Medical Diagnostic Devices.In this role, the QA Software Tester ensures that software for medical diagnostic devices is rigorously tested, compliant with regulatory standards, and meets high quality and safety standards.This role is essential for maintaining the reliability and efficacy of diagnostic devices in clinical settings.Relevant medical device regulations 8-10 years' experience and expertise (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304) working in agile environment to ensure software testing practices comply with these standards and Organizational QMS standards.Document Compliance: Ensure that software testing QMS and compliance documentation meets regulatory requirements, including test plans, test cases, test reports, and defect tracking.Test Planning and Design.Develop Test Plans: Create detailed test plans based on software requirements, design specifications, and regulatory guidelines. Define testing scope, objectives, and strategies.Design Test Cases: Develop comprehensive test cases and scenarios to validate software functionality, performance, and compliance with regulatory standards.Execution and Verification.Perform Testing: Execute manual and automated tests to verify software functionality, performance, and reliability. This includes functional testing, integration testing, system testing, and user acceptance testing.Verify Compliance: Ensure that software functions correctly in various scenarios and adheres to regulatory requirements for medical diagnostic devices.Defect Identification and ManagementDetect Defects: Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary.Manage Defects: Use defect tracking tools to manage the lifecycle of identified issues, ensuring that they are addressed in a timely manner.Documentation and Reporting.Risk ManagementCollaboration and Communication.Continuous Improvement.Validation and Verification (V&V).Training and Development.
QA Software Tester for Medical Diagnostic Devices.In this role, the QA Software Tester ensures that software for medical diagnostic devices is rigorously tested, compliant with regulatory standards, and meets high quality and safety standards.This role is essential for maintaining the reliability and efficacy of diagnostic devices in clinical settings.Relevant medical device regulations 8-10 years' experience and expertise (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304) working in agile environment to ensure software testing practices comply with these standards and Organizational QMS standards.Document Compliance: Ensure that software testing QMS and compliance documentation meets regulatory requirements, including test plans, test cases, test reports, and defect tracking.Test Planning and Design.Develop Test Plans: Create detailed test plans based on software requirements, design specifications, and regulatory guidelines. Define testing scope, objectives, and strategies.Design Test Cases: Develop comprehensive test cases and scenarios to validate software functionality, performance, and compliance with regulatory standards.Execution and Verification.Perform Testing: Execute manual and automated tests to verify software functionality, performance, and reliability. This includes functional testing, integration testing, system testing, and user acceptance testing.Verify Compliance: Ensure that software functions correctly in various scenarios and adheres to regulatory requirements for medical diagnostic devices.Defect Identification and ManagementDetect Defects: Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary.Manage Defects: Use defect tracking tools to manage the lifecycle of identified issues, ensuring that they are addressed in a timely manner.Documentation and Reporting.Risk ManagementCollaboration and Communication.Continuous Improvement.Validation and Verification (V&V).Training and Development.