Systems Analyst - Oracle Fusion PLM
Alphatec Spine•Carlsbad, CA
•$110,000 - $125,000
About The Position
The PLM Analyst supports, configures, and optimizes Oracle Fusion Cloud PLM in a regulated medical device environment. The role ensures integration among 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 analyst partners with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and IT to manage product data, engineering changes, documentation, and integrations across the product lifecycle.
Requirements
- Bachelor’s degree in Engineering, Information Systems, Quality, or a related field, or equivalent combination of education and experience.
- At least 5 years of experience with Oracle Agile PLM and/or Oracle Fusion Cloud PLM.
- 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.
- Hands-on experience with change control, document management, and BOMs.
- Experience with NiceLabel and label lifecycle management.
- Experience in the medical device industry.
- Experience with validation documentation.
- Strong analytical and problem-solving skills.
- Excellent cross-functional communication skills.
- High attention to detail and a compliance mindset.
- Ability to manage multiple priorities and assignments in a fast-paced environment.
- Ability to translate business and quality requirements into system solutions.
Nice To Haves
- Experience with Oracle Agile PLM.
- Experience with Cornerstone LMS or learning system integrations.
- Familiarity with SAP modules including MM, PP, QM, and SD.
- Experience supporting audits and regulatory inspections.
- Previous Systems Analyst experience.
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, ensuring accurate routing, approvals, and traceability.
- 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, including IQ/OQ/PQ, evidence, and traceability.
- Participate in internal and external audits related to Fusion PLM and IT systems.
- Support and monitor Oracle Fusion Cloud PLM integrations with other systems.
- Coordinate issue resolution with SAP, middleware, and integration teams and validate data consistency across systems.
- Provide Tier 2/3 support for Oracle Fusion Cloud PLM users.
- Create and maintain SOPs, work instructions, and training materials.
- Train users on Oracle Fusion PLM workflows, best practices, and compliance requirements.
- Support access management and role design in coordination with IT Security.
- Identify opportunities to streamline PLM and QMS processes.
- Partner with business stakeholders to gather, analyze, and document business requirements.
- Translate business needs and quality requirements into Oracle Fusion Cloud PLM requirements and system solutions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
