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
关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
补充雇佣信息
薪酬信息截至本职位发布之日为准。Cognizant 保留在适用法律允许的范围内随时修改该信息的权利。
申请人可能需要通过现场面试或视频会议的方式参加面试。此外，候选人在每次面试时可能需要出示其当前所在州或政府签发的有效身份证件。
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