QA Tester - Medical Devices Testing(Need local)

Lorvin Technologies - Loveland, CO

Full-time

Loveland, CO

Management of Companies and Enterprises

About the position

The QA Software Tester for Medical Diagnostic Devices plays a critical role in ensuring that software for medical diagnostic devices is rigorously tested and compliant with regulatory standards. This position is essential for maintaining the reliability and efficacy of diagnostic devices used in clinical settings, ensuring they meet high quality and safety standards.

Responsibilities

• Ensure software testing practices comply with relevant medical device regulations 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.
• 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, including 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, collaborating with development teams to resolve defects and retest as necessary.
• Use defect tracking tools to manage the lifecycle of identified issues, ensuring timely resolution.

Requirements

• Bachelor's degree in computer science, Engineering, Life Sciences, or a related field.
• 8-10 years of experience in medical device and life sciences software QMS testing, particularly in the medical device or diagnostic industry.
• Proficiency in test automation tools, programming languages, and software testing methodologies.
• Strong analytical and problem-solving skills with keen attention to detail.
• 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.

Nice-to-haves

• Advanced degrees or certifications (e.g., ISTQB, CSTE) are a plus.