| urgent new requirement for Sr. Test Lead (Medical Devices Testing) Loveland, CO 12 months at Loveland, Colorado, USA |
| Email: [email protected] |
| From: rajesh, infoways [email protected] Reply to: [email protected] Hi, Hope you are doing great. We have an urgent requirement for the below position with our IT Client HCL. Kindly reply back to this email or call me to discuss further. Job Title: Sr. Test Lead (Medical Devices Testing) Location: Loveland, CO (Onsite from Day 1; need only local candidates) Duration: 6 Months Job Description: Role: QA Software Tester for Medical Diagnostic Devices 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. An expert in Medical Devices who has been a tester for major biotech companies like Siemens, Roche, BD, etc. The person should know software (and hardware) and how devices interface with HL7, ASTM, LISLIMS can be tested. Evaluate the safety of a new medical device Responsibilities: 1. Regulatory Compliance and Standards Adherence: 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. 2. Test Planning and Design: 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. 3. Execution and Verification: 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. 4. Defect Identification and Management: o Detect Defects: Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary. o Manage Defects: Use defect tracking tools to manage the lifecycle of identified issues, ensuring that they are addressed in a timely manner. 5. Documentation and Reporting: 6. Risk Management: 7. Collaboration and Communication: 8. Continuous Improvement: 9. Validation and Verification (V&V): 10. Training and Development: Skills and Qualifications: Educational Background: Bachelors degree in computer science, Engineering, Life Sciences, or a related field. Advanced degrees or certifications (e.g., ISTQB, CSTE) are a plus. Experience: 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. Technical Skills: Proficiency in test automation tools, programming languages, and software testing methodologies. Familiarity with medical device software development and testing standards. Attention to Detail: Strong analytical and problem-solving skills with a keen attention to detail to identify and address software issues. Communication Skills: Excellent verbal and written communication skills to effectively interact with development teams, regulatory bodies, and stakeholders. Regulatory Knowledge: In-depth knowledge of regulatory standards and guidelines relevant to medical device software, including risk management and compliance requirements. Best Regards Rajesh InfoWays Phone#: 609-858-0846 Email:[email protected] Visit us at: www.info-ways.com Keywords: quality analyst information technology Colorado urgent new requirement for Sr. Test Lead (Medical Devices Testing) Loveland, CO 12 months [email protected] |
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| Wed Sep 25 19:24:00 UTC 2024 |