Cadwell

Document Control Specialist 1

Kennewick, WA

Sponsorship not specified$22k-$33kDetected 33 days ago

GitComplianceERPHRMedical Devices

About the role

They review and execute Engineering Changes, updates to Cadwell processes, part number requests, and regulatory compliance documentation.
Reviews and processes Engineering Changes (ECs), ensuring changes are clearly documented following standard good documentation practices
Processes part number requests, including creating item records in Cadwell's ERP system

Implements Bills of Materials (BOMs) 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
Performs other duties as assigned
Manages Cadwell's documentation in accordance with company and regulatory requirements, ensures accurate and complete version control
Ensures document control activities follow written processes in compliance with ISO 13485, company requirements, and other applicable regulatory requirements
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.

Extensive use of a computer will be required.
Travel may be required
must be able to obtain necessary travel documents.
Work hours outside normal business hours may be required at times to meet business needs.
Knowledge, Skills, and Abilities:

Working knowledge of version control best practices
Working knowledge of engineering change control processes
Preferred Working knowledge of good documentation practices (GDP)
Preferred Working knowledge of Enterprise Resource Planning (ERP) systems and BOMs structures
Strong attention to detail with a high degree of accuracy

Processes regulatory compliance documentation, ensuring full compliance with 21 CFR Part 11 and company requirements

If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at careers@cadwell.com

t of every person to participate in all aspects of employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic info

This listing is sourced directly from Cadwell's careers page and normalized into a canonical job model.