Document Control Specialist 1

Cadwell • Kennewick, WA

10h • $22 - $33 • Onsite

About The Position

The Document Control Specialist 1 executes and enforces the Document Control processes and systems used to support Cadwell’s industry-leading neuro-diagnostics equipment. The Document Control Specialist organizes, manages, and controls Cadwell’s current and historical documentation repositories in accordance with Company and regulatory requirements. They review and execute Engineering Changes, updates to Cadwell processes, part number requests, and regulatory compliance documentation.

Requirements

• Working knowledge of version control best practices
• Working knowledge of engineering change control processes
• Work as part of a cross-functional team with a professional and solutions-oriented approach; ability to manage more than one effort at once
• Strong attention to detail with a high degree of accuracy
• Associate’s degree in technical field or equivalent worked experience
• Typically at least one (1) year of relevant document control experience or related work

Nice To Haves

• Working knowledge of good documentation practices (GDP)
• Working knowledge of Enterprise Resource Planning (ERP) systems and BOMs structures
• Preferred experience working in a regulated environment, ideally in a medical or similar engineering and/or quality focused industry

Responsibilities

• Manages Cadwell’s documentation in accordance with company and regulatory requirements, ensures accurate and complete version control
• Reviews and processes Engineering Changes (ECs), ensuring changes are clearly documented following standard good documentation practices
• Implements Bills of Materials (BOMs) in Cadwell’s ERP system
• Processes regulatory compliance documentation, ensuring full compliance with 21 CFR Part 11 and company requirements
• Processes part number requests, including creating item records in Cadwell’s ERP system
• Provides support during internal and external audits by providing requested documentation and demonstrating overall accuracy of the document control system
• Ensures document control activities follow written processes in compliance with ISO 13485, company requirements, and other applicable regulatory requirements
• Executes small projects in documentation focused areas
• Performs other duties as assigned

Benefits

• Equal Opportunity Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree