PLM/QMS Systems Analyst - Medical Device (Oracle Fusion)

ATEC Spine; Carlsbad (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

ATEC Spine is seeking a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM within a regulated medical device environment. You will coordinate with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and IT to manage product data, changes, and system integrations across the lifecycle.

The role requires 5-8 years in Agile PLM, PLM/QMS experience in medical devices, and strong knowledge of FDA/ISO13485.

Qualifications

• Bachelor's degree in Engineering, Information Systems, Quality, or related field.
• 5-8 years of experience with Agile PLM (Oracle Fusion Cloud preferred).
• Experience supporting QMS processes in a regulated medical device environment.
• Experience with SAP S/4HANA integration with PLM systems.
• Knowledge of FDA 21 CFR 820, ISO 13485, and medical device regulations.

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.

Skills

Analytical thinking

Problem solving

Cross-functional communication

Attention to detail

Time management

Education

Bachelor's degree in Engineering, Information Systems, Quality, or related field

Tools

Oracle Fusion Cloud PLM

SAP S/4HANA

NiceLabel

Cornerstone LMS

SOP/Documentation tools

Job description

ATEC Spine is seeking a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM within a regulated medical device environment. You will coordinate with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and IT to manage product data, changes, and system integrations across the lifecycle.

The role requires 5-8 years in Agile PLM, PLM/QMS experience in medical devices, and strong knowledge of FDA/ISO13485.