Job Title: Document Control Specialist

Work Location: Sarasota County, FL

Summary:

The Document Control Specialist plays a vital role in supporting quality initiatives, document management, and change control processes. This position collaborates with multiple departments to ensure compliance, accuracy, and continuous improvement in documentation and data management systems.

Responsibilities:

• Administer and maintain document control databases, ensuring accurate processing of change orders and document revisions.
• Lead and coordinate change control board (CCB) activities, facilitating communication and documentation across departments.
• Review, proofread, and create redlines for proposed document and drawing changes to ensure compliance with standards.
• Generate quality and compliance reports, proactively recommending process improvements and supporting audit activities.
• Provide training on engineering change requests (ECR), engineering change orders (ECO), and product data management processes.
• Assist with new product introductions, supporting data management and project management responsibilities.
• Ensure all documents meet format standards prior to submission and support periodic review initiatives.
• Collaborate with various departments to coordinate change activities, document retention, and continuous improvement efforts.

Qualifications:

• 3 to 5 years of related experience and/or training, or equivalent combination of education and experience.
• Experience with product lifecycle and data management systems (PLM) and ERP systems.
• Intermediate or above proficiency in Microsoft Office Suite.
• Experience with medical device manufacturing in compliance with ISO 13485 or FDA preferred.
• Excellent verbal and written communication skills; ability to present information to all audience levels.
• Highly detail-oriented with strong analytical and problem-solving skills.
• Self-motivated, proactive, and customer service oriented.
• Strong project management skills and ability to organize and present data effectively.
• Ability to establish and maintain effective working relationships across departments.

Published Category: Quality & Validation