QA Tester - Medical Devices Testing

Katalyst HealthCares & Life Sciences


Date: 3 days ago
City: Loveland, CO
Contract type: Contractor
Responsibilities

  • 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.
  • Ensure that software testing QMS and compliance documentation meets regulatory requirements, including test plans, test cases, test reports, and defect tracking.
  • Create detailed test plans based on software requirements, design specifications, and regulatory guidelines. Define testing scope, objectives, and strategies.
  • Develop comprehensive test cases and scenarios to validate software functionality, performance, and compliance with regulatory standards.
  • Execute manual and automated tests to verify software functionality, performance, and reliability. This includes functional testing, integration testing, system testing, and user acceptance testing.
  • Ensure that software functions correctly in various scenarios and adheres to regulatory requirements for medical diagnostic devices.
  • Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary.
  • 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.

Requirements:

  • Bachelor's degree in computer science, Engineering, Life Sciences, or a related field.
  • Advanced degrees or certifications (e.g., ISTQB, CSTE) are a plus.
  • 8-10 in medical device and life sciences software QMS testing, particularly in the medical device or diagnostic industry, with a strong understanding of regulatory requirements and quality standards.
  • Proficiency in test automation tools, programming languages, and software testing methodologies.
  • Familiarity with medical device software development and testing standards.
  • Strong analytical and problem-solving skills with a keen attention to detail to identify and address software issues.
  • Excellent verbal and written communication skills to effectively interact with development teams, regulatory bodies, and stakeholders.
  • In-depth knowledge of regulatory standards and guidelines relevant to medical device software, including risk management and compliance requirements.

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