Document Control Coordinator

Key Responsibilities

• Cook up document control activities including distribution, tracking, and auditing of controlled documents
• Maintain electronic document systems and department directories
• Manage archival of controlled documents and validation files
• Administer the electronic document management system
• Lead ECR and ECO processes and support weekly change control meetings
• Support Quality Management System audits and compliance activities
• Review and update specifications based on customer and regulatory changes
• Interpret engineering changes, revisions, and specifications and communicate across teams
• Cook up the RMA process including issuing numbers, tracking status, and reporting
• Develop and maintain metrics for document control and RMA performance

Qualifications

• A High School diploma or equivalent is required
• A Bachelor’s degree in a technical field is preferred
• 1 to 3 years of experience in a manufacturing environment
• Experience with engineering and manufacturing documentation practices
• Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820, or AS9100 is a plus

Skills

• A strong attention to detail and organization
• The ability to manage multiple priorities and meet deadlines
• A clear communication and cross-functional collaboration
• A comfort in a fast-paced environment
• A self-starter with a growth mindset
• A proficiency in Microsoft Excel and Office Suite

Physical Requirements

• The ability to sit or stand for extended periods
• Occasional walking, bending, and reaching
• The ability to lift up to 50 lbs as needed