Systems Analyst- PLM/QMS

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
• Manage and support ECO, MCO, CR, Deviations, and other change workflows
• Maintain DHF, DMR, and technical documentation within PLM
• Support Computer System Validation (CSV) activities including IQ/OQ/PQ
• Coordinate issue resolution with SAP, middleware, and integration teams
• Provide Tier 2/3 support for Oracle Fusion Cloud PLM users
• Train users on Oracle Fusion PLM workflows and compliance requirements
• Partner with business stakeholders to gather and document business requirements

Requirements

• Bachelor’s degree in Engineering, Information Systems, Quality, or related field
• 5–8 years of experience working with Agile PLM or Oracle Fusion Cloud PLM
• Experience supporting QMS processes in a regulated medical device environment
• Knowledge of FDA 21 CFR 820 and ISO 13485 regulations
• Experience with SAP S/4HANA integration with PLM systems
• Hands-on experience with change control, document management, and BOMs
• Experience with NiceLabel and label lifecycle management
• Experience with validation documentation and supporting audits
• Familiarity with SAP modules such as MM, PP, QM, or SD

About the Company

Alphatec Spine (ATEC) is a medical device company focused on providing advanced spinal solutions.