Job Summary
We are looking for Lead Product Test Consultant with a focus on document and validate software installed on medical laboratory instrumentation according to EMA guidelines.
Responsibilities
- Document and validate software installed on medical laboratory instrumentation according to EMA guidelines.
- Lead the development and execution of comprehensive test strategies for regulatory compliance projects.
- Provide expert guidance on compliance management and regulatory affairs operations.
- Document software specifications Create infrastructure diagrams and Create data flow diagrams
- Perform risk assessments
- Collaborate with cross functional teams to ensure seamless integration of compliance requirements.
- Develop and maintain documentation for testing processes and compliance standards.
- Ensure timely delivery of testing milestones and compliance reports.
- Facilitate communication between stakeholders to address compliance related concerns.
- Implement best practices for testing and compliance management to enhance efficiency.
- Support the training and development of team members in compliance testing methodologies.
- Contribute to the continuous improvement of testing frameworks and tools.
- Drive the adoption of innovative testing solutions to meet evolving regulatory requirements.
- Write validation test cases and document software specifications
Certifications Required
Optional
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
