Lead Document Controller - Medical Devices & QMS

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Aurora Lifesciences is seeking an experienced Senior Document Controller to manage controlled documentation and quality records within a regulated manufacturing environment. The role ensures documents are accurate, approved, traceable and available, supporting ISO13485 compliance and regulatory requirements.

You will partner with Quality, Regulatory, Manufacturing and Engineering teams, oversee change control, document lifecycle, audits, and training; supervise junior staff and drive process

Qualifications

• 7+ years in Quality, Quality Systems or document control in medical devices or regulated industry.
• Experience with ISO13485 Quality Management System.
• Knowledge of 21 CFR Part 820 or equivalent regulations.

Responsibilities

• Process document, item and engineering change requests per change control procedures.
• Review change orders for accuracy and approvals.
• Manage creation, review, approval, issue, revision, withdrawal and archiving of controlled documents.
• Ensure quality records are filed and retained per ISO13485 and procedures.
• Assign document numbers, revision levels and identifiers.
• Maintain document registers and training records.
• Ensure current document versions are available at use points.
• Retrieve records for audits and inspections.
• Train employees on document control and ISO13485 requirements.
• Support and supervise junior team members.
• Identify improvements to processes and electronic systems.

Skills

Attention to detail

ISO13485 knowledge

Change control

Document management

Reading drawings/specs

Communication skills

Multi-priority management

Proactive mindset

Tools

eQMS

PLM platform

Document management system

Job description

Aurora Lifesciences is seeking an experienced Senior Document Controller to manage controlled documentation and quality records within a regulated manufacturing environment. The role ensures documents are accurate, approved, traceable and available, supporting ISO13485 compliance and regulatory requirements.

You will partner with Quality, Regulatory, Manufacturing and Engineering teams, oversee change control, document lifecycle, audits, and training; supervise junior staff and drive process