QA Tester - Medical Devices Testing

Company : Katalyst HealthCares & Life Sciences

Location : Loveland, CO, 80537

Posted Date : 15 September 2025

Job Type : Other

Category : Information Design & Documentation

Occupation : QA Tester

Job Details

Responsibilities and Requirements:

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.

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.

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.

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.

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