Documentation Control Specialist

Confluent Medical Technologies - Austin, TX

Full-time

Austin, TX

Miscellaneous Manufacturing

About the position

The Document Control Specialist at Confluent Medical Technologies is responsible for managing and maintaining document control records and related files, ensuring compliance with company standards and industry regulations. This role involves executing document control tasks, providing training, and supporting records management to facilitate the production of high-quality medical devices.

Responsibilities

• Compiles and maintains document control records and related files.
• Executes Document Control tasks, including review of requested changes and ensuring required training is complete.
• Confers with document originators or engineering liaison personnel to resolve discrepancies.
• Makes public electronic versions of documents on the network server and distributes controlled copies.
• Provides training for the Document Control System.
• Maintains document list for all suppliers and customers.
• Prepares document process metrics and examines change orders for completeness and accuracy.
• Executes updates to ERP system items to reflect released changes.
• Maintains related files and prepares requests for reproduction of documents.
• Acts as gatekeeper for hard copy quality records, ensuring good documentation practices (GDP).
• Supports records management and maintains records including supplier files and lot records.
• Scans files, creates document indexes, and prepares boxes for off-site storage.
• Enters training history into the training database and tracks on-time training performance.
• Works on advanced projects compiling and analyzing data and creating reports.
• Monitors external standards as assigned and follows all standard operating procedures.

Requirements

• High school diploma or GED plus 3+ years of related experience in Document Control and Change Management.
• General knowledge of medical device GMPs and GDPs is strongly preferred.
• Strong proficiency with PCs and associated software, including databases.
• Ability to use online document retrieval systems.
• Good written and oral English communication skills.