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Siemens Healthineers · 12 hours ago

Document Control Change Analyst

Knoxville, TN

Full-time

Onsite

New Grad, Entry Level

$89K/yr - $123K/yr

Siemens Healthineers is a leader in medical technology, dedicated to creating better outcomes for patients worldwide. The Document Control Change Analyst will provide documentation and quality management system support, assisting with the maintenance of the Engineering Change Notice System and coordinating interactions to ensure proper documentation for audit purposes.

Health CareHealth DiagnosticsMedicalMedical Device

Responsibilities

Assists with maintenance of Engineering Change Notice System for product improvements, repairs and new product development. within the Agile PLM System

Creates and maintains workflows within the Agile PLM system

Monitors and maintains Agile PLM System

Coordinates the interaction between engineering, manufacturing, field operations and marketing to ensure all changes are documented for audit purposes (may include FDA, ISO, IEEE)

Guides effective interaction between Engineering and Development and Operations to ensure all changes are documented for audit purposes

Works cross-functionally with engineering, sales, and PETNET production to successfully implement strategic initiatives

Incorporates new technology, products and processes into daily operation

Works in compliance with all regulatory standards including EH&S, cGMP, Radiation Safety, applicable pharmacy laws, DOT, and internal policies and interpretations of the above as required

Qualification

Agile PLM SystemDocumentation ManagementQuality Management SystemsRegulatory ComplianceCross-functional CollaborationEffective Communication

Required

Functions as part of a team to provide documentation and quality management system support to people engaged in the research and development; production of PET biomarkers; and/or corporate support roles

Assists with maintenance of Engineering Change Notice System for product improvements, repairs and new product development within the Agile PLM System

Creates and maintains workflows within the Agile PLM system

Monitors and maintains Agile PLM System

Coordinates the interaction between engineering, manufacturing, field operations and marketing to ensure all changes are documented for audit purposes (may include FDA, ISO, IEEE)

Guides effective interaction between Engineering and Development and Operations to ensure all changes are documented for audit purposes

Works cross-functionally with engineering, sales, and PETNET production to successfully implement strategic initiatives

Incorporates new technology, products and processes into daily operation

Works in compliance with all regulatory standards including EH&S, cGMP, Radiation Safety, applicable pharmacy laws, DOT, and internal policies and interpretations of the above as required

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Company

Siemens Healthineers

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Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.

Founded in 1847