Systems Analyst- PLM/QMS

Job description

The PLM Analyst is responsible for supporting, configuring, and optimizing the Oracle Fusion Cloud PLM within a regulated medical device environment. This role ensures seamless integration between Oracle Fusion Cloud PLM, SAP S/4HANA, NiceLabel, and Cornerstone, while maintaining compliance with FDA, ISO 13485, and internal Quality Management System (QMS) requirements. The PLM Analyst partners closely with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and IT to manage product data, engineering changes, documentation, and system integrations across the product lifecycle. Essential Duties and Responsibilities: - Serve as the primary administrator and subject-matter expert for Oracle Fusion Cloud PLM. - Configure workflows, attributes, user roles, permissions, and lifecycle states. - Maintain product structures, BOMs, specifications, drawings, and metadata. - Support system upgrades, enhancements, and quarterly Fusion Cloud releases. - Manage and support ECO, MCO, CR, Deviations, and other change workflows. - Ensure accurate routing, approvals, and traceability of changes. - Maintain DHF, DMR, and technical documentation within PLM. - Support New Product Introduction (NPI/NPD...