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Document Control Specialist

1 month ago

Saint Charles, Missouri, United States AJR Group Full time
Job Summary

We are seeking a highly organized and detail-oriented Document Control Specialist to join our team at AJR Group. As a key member of our quality management team, you will be responsible for developing and implementing a paper-based Quality Management System (QMS) document management process to ensure regulatory compliance.

Key Responsibilities:

  • Develop, implement, and maintain a QMS document management process to ensure regulatory compliance.
  • Maintain master and obsolete copies of controlled documents, including engineering drawings, bills of material, manufacturing outlines, and manuals.
  • Manage the Master Document Distribution List and other documentation, such as Engineering Change Order (ECO) folders.
  • Obtain review and approval for new or revised controlled documents, ensuring adherence to quality standards.
  • Research and resolve issues related to controlled documents using available resources, including masters, ECO files, and logs.
  • Create and assist in the creation of Engineering Change Orders (ECOs), including tracking, implementing, and closing them efficiently.
  • Compare redlines with completed engineering documents for accuracy and notify the Quality & Regulatory Manager or engineers of any discrepancies.
  • Maintain remote hard copies, calibration records, and records of controlled documents for compliance.
  • Format and revise customer-oriented documents, such as Instructions for Use, as directed.
  • Manage training logs, create training plans, and coordinate training sessions for employees, maintaining training matrices and assessing training needs.
  • Monitor training records to ensure compliance with quality standards and track employee progress effectively.
  • File hard copies of employee records and maintain training and signature records to ensure accurate documentation.
  • Collaborate with department heads to identify training needs and create relevant training materials.
  • Assist in preparing and executing internal and external audits to maintain compliance with ISO standards.
  • Perform other tasks as assigned to support continuous improvement initiatives.

Requirements:

  • Proficient in tracking document history and resolving issues using available resources.
  • Excellent written and verbal English communication skills.
  • Strong computer skills, including expertise in Word, Excel, and MS Outlook.
  • Exceptional problem analysis, problem-solving abilities, and attention to detail.
  • Highly organized, detail oriented and strong on interpersonal skills.
  • Hands-on experience with records management and change control process.
  • Ability to read and interpret engineering drawings.

Preferences:

  • Bachelor's degree in a related field (e.g., Quality Assurance, Business Administration, Life Sciences)
  • 2+ years of experience in document control or training coordination within the medical device industry.
  • Knowledge of ISO 9000 and ISO 13485 standards.
  • Familiar with Sage100 software.