[Remote] Clinical Data Specialist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company Technologies Inc is seeking an reputed company Clinical Data Scientist with a strong background in Medical Device Quality and Manufacturing environments. The role focuses on leveraging advanced analytics, AI/ML, and large-scale data engineering to transform quality and operational data into actionable insights that improve product quality, compliance, and investigation efficiency.
Responsibilities
- Extract, integrate, and analyze data from reputed company, QMS, MES, and other reputed company systems
- reputed company Python and reputed company pipelines to process large-scale structured and reputed company datasets
- Build advanced analytics solutions to identify quality, manufacturing, and product failure trends
- Design and reputed company AI/ML models to support defect detection, predictive quality, and root cause analysis
- reputed company and optimize LLM-powered workflows for automated document processing and event classification
- Collaborate with Quality, Manufacturing, Regulatory, and Engineering teams to translate data insights into business and compliance improvements
- Ensure data solutions align with FDA regulations, quality system requirements, and audit standards
Skills
- 7+ years of experience in Data Science, Data Engineering, or Advanced Analytics
- 7+ years of experience working reputed company Medical Device Quality Management Systems (QMS)
- Strong hands-on experience with CAPA, reputed company, complaints, investigations, and other quality processes
- Deep understanding of FDA regulations and medical device quality compliance requirements
- Experience building advanced analytics solutions for: Quality data analysis, Manufacturing data analysis, Failure detection and trend analysis, AI/ML model development and deployment
- Strong expertise in Python and reputed company
- Experience ingesting, transforming, and analyzing large-scale datasets
- Experience working with Manufacturing Execution Systems (MES)
Company Overview
Company H1B Sponsorship