Document Control Specialist 1 (Medtech)

TL;DR

Document Control Specialist 1 (Medtech): Managing and enforcing document control processes for neuro-diagnostics equipment with an accent on version control, regulatory compliance, and engineering changes. Focus on maintaining accurate documentation repositories, implementing BOMs in ERP systems, and ensuring adherence to ISO 13485 and 21 CFR Part 11.

Location: Onsite in Kennewick, WA

Salary: $22 - $33 per hour

Company

hirify.global develops and manufactures industry-leading neuro-diagnostics equipment.

What you will do

• Manage documentation repositories and ensure strict version control in accordance with regulatory requirements.
• Review and execute Engineering Changes (ECs) following standard good documentation practices.
• Implement Bills of Materials (BOMs) and create item records within the ERP system.
• Process and maintain regulatory compliance documentation, specifically following 21 CFR Part 11.
• Support internal and external audits by providing accurate documentation and system demonstrations.
• Ensure all document control activities comply with ISO 13485 and company processes.

Requirements

• Associate's degree in a technical field or equivalent work experience.
• At least 1 year of relevant document control experience.
• Working knowledge of version control and engineering change control processes.
• Must be based in or able to work onsite in Kennewick, WA.
• Strong attention to detail and high degree of accuracy.

Nice to have

• Knowledge of Good Documentation Practices (GDP).
• Experience with Enterprise Resource Planning (ERP) systems and BOM structures.
• Prior experience in a regulated environment, particularly in medical device or engineering industries.

Culture & Benefits

• Equal Opportunity Employer with a commitment to diversity and inclusion.
• Collaborative, cross-functional team environment.
• Professional, solutions-oriented approach to work and problem-solving.