Job Description

Job Title: Specialist, Document Control

12 month contract

Hybrid in Redmond, WA

Must be able to work on a W2

This is an individual contributor role requiring sound judgment and the ability to work independently with minimal supervision. The role involves administering Device Master Records (DMR), Change Orders, and quality records in accordance with corporate documentation procedures and FDA Good Manufacturing Practices (GMP).

Key responsibilities include:

• Overseeing engineering change documentation.
• Ensuring the accuracy and reliability of document databases.
• Maintaining both hard copy and electronic DMR files.
• Providing training and technical support within the document center and to other user groups involved in Product Lifecycle Management (PLM).

Job Responsibilities

• Administer DMRs, Specifications, Change Orders, Parts, and Bills of Material through release and distribution, per corporate and departmental guidelines.
• Evaluate and ensure accuracy and completeness of DMR documentation and change records with document creators and reviewers.
• Collaborate cross-functionally (engineering, purchasing, quality, manufacturing) to meet documentation and BOM requirements.
• Provide PLM and ERP tool training and support to team members and stakeholders.
• Manage current and historical DMR files per filing standards, retention policies, and GMP.
• Support configuration management and continuous improvement initiatives (e.g., Kaizens).
• Establish and maintain document center guidelines and procedures.
• Enforce data governance policies for accuracy, consistency, and compliance.
• Provide technical support to users and departments on DMR documentation, GMP processes, and PLM systems.
• Contribute to technology projects involving updates to regulatory and production data (e.g., UDI, ACE, PMA, MDD) and product master data tables to support the Order to Cash process.

Job Qualifications

• Bachelor’s Degree (required).
• 3–5 years of experience in configuration control, or
• 5 years of combined experience with at least 3 years in configuration control and the remainder in production.
• Intermediate to advanced proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, Access).

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