Systems Analyst- PLM/QMS

About the role

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.

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).
• 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.
• 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 into Oracle Fusion Cloud PLM requirements.

Requirements

• Bachelor's degree in Engineering, Information Systems, Quality, or related field.
• 5-8 years of experience working 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.
• Hands-on experience with change control, document management, and BOMs.
• Experience with NiceLabel and label lifecycle management.
• Experience working in the Medical Device Industry.
• Experience with Cornerstone LMS or learning system integrations.
• Experience with validation documentation.
• Familiarity with SAP modules (MM, PP, QM, SD).
• Experience supporting audits and regulatory inspections.
• Strong analytical and problem-solving skills.
• Excellent cross-functional communication.
• High attention to detail and compliance mindset.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to translate business and quality requirements into system solutions.
• Demonstrated ability to handle multiple assignments with attention to detail.
• Minimum 4‑year Bachelor Degree or equivalent combination of education and experience.
• Minimum 5 years' experience in Oracle Agile PLM / Oracle Fusion Cloud PLM.
• Previous Systems Analyst experience desired.

Pay

Alphatec Spine, Inc. complies with state and federal wage and hour laws; compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. Salary range: $110,000 to $125,000 Full‑Time Annual Salary.