Oracle Fusion PLM Specialist for Medical Devices & QMS

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

Job summary

Alphatec Spine, Inc. seeks a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM in a regulated medical device environment, ensuring integration with SAP S/4HANA, NiceLabel, and Cornerstone while maintaining FDA/ISO13485 compliance.

You will collaborate with R&D, Quality, Regulatory, Manufacturing, and IT to manage product data, engineering changes, documentation, and system integrations across the product lifecycle.

Qualifications

• Bachelor's degree in engineering, information systems, quality, or related field.
• 5-8 years of experience with Oracle Fusion Cloud PLM; Oracle Agile PLM preferred.
• Experience with QMS in a regulated medical device environment.
• Experience with SAP S/4HANA integration with PLM.
• Knowledge of FDA 21 CFR 820 and ISO 13485.
• Hands-on change control, document management, and BOM experience.
• Experience with NiceLabel and label lifecycle management.
• Medical device industry experience.
• Experience with Cornerstone LMS integrations.
• Experience with validation documentation.
• Familiarity with SAP modules (MM, PP, QM, SD).
• Audits and regulatory inspections experience.
• Strong communication and detail orientation.

Responsibilities

• Serve as the primary administrator 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 and quarterly Fusion Cloud releases.
• Manage ECO, MCO, CR, Deviations, and change workflows.
• Ensure accurate routing, approvals, and traceability of changes.
• Maintain DHF, DMR, and technical documentation within PLM.
• Support NPI/NPD and sustaining engineering activities.
• Support QMS processes managed within PLM or integrated systems.
• Support CSV activities (IQ/OQ/PQ, evidence, traceability).
• Participate in audits related to Fusion PLM and IT systems.
• Support PLM integrations with other systems.
• Coordinate issue resolution with SAP and integration teams.
• Validate data consistency across systems.
• Provide Tier 2/3 support for PLM users.
• Create and maintain SOPs, work instructions, and training materials.
• Train users on PLM workflows, best practices, and compliance requirements.
• Support access management and role design with IT Security.
• Identify opportunities to streamline PLM and QMS processes.
• Translate business requirements into PLM specifications.

Skills

Analytical skills

Problem solving

Cross-functional communication

Attention to detail

Compliance mindset

Prioritization under pressure

System requirements translation

Education

Bachelor's degree in Engineering / Information Systems / Quality

4+ years combined education/experience

5+ years Oracle Fusion Cloud PLM / Oracle Agile PLM experience

Tools

Oracle Fusion Cloud PLM

Oracle Agile PLM

SAP S/4HANA integration with PLM

NiceLabel

Cornerstone LMS

Job description

Alphatec Spine, Inc. seeks a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM in a regulated medical device environment, ensuring integration with SAP S/4HANA, NiceLabel, and Cornerstone while maintaining FDA/ISO13485 compliance.

You will collaborate with R&D, Quality, Regulatory, Manufacturing, and IT to manage product data, engineering changes, documentation, and system integrations across the product lifecycle.