[Remote] Clinical Data Specialist

Note: The job is a remote job and is open to candidates in USA. United Pharma Technologies Inc is seeking an experienced 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 SAP, QMS, MES, and other enterprise systems
• Develop Python and Databricks pipelines to process large-scale structured and unstructured datasets
• Build advanced analytics solutions to identify quality, manufacturing, and product failure trends
• Design and deploy AI/ML models to support defect detection, predictive quality, and root cause analysis
• Develop 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 within Medical Device Quality Management Systems (QMS)
• Strong hands-on experience with CAPA, NCR, 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 Databricks
• Experience ingesting, transforming, and analyzing large-scale datasets
• Experience working with Manufacturing Execution Systems (MES)

Company Overview

Company H1B Sponsorship