QA Tester - Medical Devices Testing Job at Katalyst CRO in Loveland

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Position: QA Software Tester for Medical Diagnostic Devices.

In this role, you will ensure 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.

Requirements include 8-10 years of experience and expertise in relevant medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304). You should have experience working in an agile environment to ensure software testing practices comply with these standards and organizational QMS standards.

Key responsibilities:

1. Document Compliance: Ensure testing QMS and compliance documentation meet regulatory requirements, including test plans, test cases, test reports, and defect tracking.
2. Test Planning and Design: Develop detailed test plans and comprehensive test cases based on software requirements and regulatory guidelines.
3. Execution and Verification: Perform manual and automated testing, verify software functionality, performance, and compliance, and ensure proper defect management.
4. Documentation and Reporting: Maintain accurate records of testing activities and outcomes.
5. Collaboration and Communication: Work effectively with development teams and stakeholders.
6. Validation and Verification (V&V): Conduct V&V activities to confirm software meets all specifications.
7. Training and Development: Stay updated with industry standards and improve testing skills.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Quality Assurance

Industry: Pharmaceutical Manufacturing

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