QA Tester - Medical Devices Testing Job at Katalyst Healthcares and Life Sciences, Loveland, CO

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  • Katalyst Healthcares and Life Sciences
  • Loveland, CO

Job Description

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 Management
  • Detect 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 Management
  • Collaboration and Communication.
  • Continuous Improvement.
  • Validation and Verification (V&V).
  • Training and Development.

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