Systems Analyst- PLM/QMS

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) and sustaining engineering activities.
• Support QMS processes managed within PLM or integrated systems.
• Support Computer System Validation (CSV) activities (IQ/OQ/PQ, evidence, traceability)