Senior Document Control Specialist

Job Summary

A company is looking for a Sr. Document Control Specialist.

Key Responsibilities

• Lead the maintenance and continuous improvement of the Document Management System (DMS)
• Ensure technical documentation and filings are complete and reflect current practice
• Support regulatory, customer, and internal audits while assisting in quality management system activities

Required Qualifications, Training, and Education

• Associate's degree in a relevant field or equivalent experience
• 2 - 4 years of experience in a regulated industry as a document control specialist
• Experience creating and maintaining both paper and electronic records
• Basic knowledge of Quality System Regulations, including 21 CFR 11, 21 CFR 820, and ISO 13485
• Experience interacting with Regulatory Authorities