What are the responsibilities and job description for the QA Tester - Medical Devices Testing position at TekOne IT Services Pvt. Ltd.?
Regulatory Compliance and Standards Adherence:
Ensure software testing complies with relevant medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Maintain adherence to Organizational QMS standards.
Prepare and maintain compliance documentation including test plans, test cases, test reports, and defect tracking logs.
Test Planning and Design:
Develop detailed test plans based on software requirements and design specifications.
Define testing objectives, scope, and strategies aligned with regulatory guidelines.
Design comprehensive test cases to ensure software functionality, performance, and compliance with regulatory standards.
Execution and Verification:
Execute both manual and automated tests to verify software functionality, performance, and reliability.
Conduct functional testing, integration testing, system testing, and user acceptance testing to ensure system compliance.
Ensure software functions adhere to regulatory standards in various clinical scenarios.
Defect Identification and Management:
Identify, document, and track software defects and issues.
Collaborate with development teams to resolve defects and retest as necessary.
Manage defect tracking using appropriate tools to ensure timely resolution.
Documentation and Reporting:
Prepare clear and detailed test reports and documentation for submission to relevant stakeholders.
Ensure all testing documentation aligns with regulatory standards.
Risk Management:
Participate in risk assessments and develop risk mitigation strategies for software testing.
Collaboration and Communication:
Work closely with cross-functional teams including development, quality assurance, and regulatory teams to ensure project success.
Effectively communicate test results and issues to stakeholders.
Continuous Improvement:
Identify areas for improvement in testing processes and propose innovative solutions.
Keep up to date with advances in test automation and medical device standards.
Validation and Verification (V&V):
Lead validation and verification efforts, ensuring full adherence to medical device regulatory requirements.
Training and Development:
Provide training to junior testers and ensure compliance with the best testing practices.
Skills And Qualifications
Educational Background: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field. Advanced degrees or certifications (e.g., ISTQB, CSTE) are preferred.
Experience:
8-10 years of experience in software testing, with a focus on medical devices or diagnostic systems.
Strong experience with QMS software testing.
Technical Skills:
Proficiency in test automation tools, programming languages, and various software testing methodologies.
Knowledge of medical device software development and testing standards.
Attention to Detail:
Strong analytical and problem-solving skills with the ability to detect and address software issues.
Communication Skills:
Excellent verbal and written communication skills for effective collaboration with development teams, regulatory bodies, and stakeholders.
Regulatory Knowledge:
Deep understanding of FDA 21 CFR Part 820, ISO 13485, and other medical device software regulations.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a QA Tester - Medical Devices Testing?
Sign up to receive alerts about other jobs on the QA Tester - Medical Devices Testing career path by checking the boxes next to the positions that interest you.
