[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.ResponsibilitiesExtract, integrate, and analyze data from SAP, QMS, MES, and other enterprise systemsDevelop Python and Databricks pipelines to process large-scale structured and unstructured datasetsBuild advanced analytics solutions to identify quality, manufacturing, and product failure trendsDesign and deploy AI/ML models to support defect detection, predictive quality, and root cause analysisDevelop and optimize LLM-powered workflows for automated document processing and event classificationCollaborate with Quality, Manufacturing, Regulatory, and Engineering teams to translate data insights into business and compliance improvementsEnsure data solutions align with FDA regulations, quality system requirements, and audit standardsSkills7+ years of experience in Data Science, Data Engineering, or Advanced Analytics7+ years of experience working within Medical Device Quality Management Systems (QMS)Strong hands-on experience with CAPA, NCR, complaints, investigations, and other quality processesDeep understanding of FDA regulations and medical device quality compliance requirementsExperience building advanced analytics solutions for: Quality data analysis, Manufacturing data analysis, Failure detection and trend analysis, AI/ML model development and deploymentStrong expertise in Python and DatabricksExperience ingesting, transforming, and analyzing large-scale datasetsExperience working with Manufacturing Execution Systems (MES)Company OverviewUnited Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors. It was founded in 2010, and is headquartered in South Plainfield, New Jersey, USA, with a workforce of 201-500 employees. Its website is https://unitedpharma.us/.Company H1B SponsorshipUnited Pharma Technologies Inc has a track record of offering H1B sponsorships, with 5 in 2026, 50 in 2025, 81 in 2024, 77 in 2023, 69 in 2022, 46 in 2021, 57 in 2020. Please note that this does not guarantee sponsorship for this specific role.