Document Control Specialist

The Document Control Specialist supports the quality department through control of documents, records and training management required in all aspects of quality assurance and regulatory compliance activities.

Responsibilities:

• Control and maintain quality documentation in accordance with internal procedures and external regulatory standards and guidance

• Administrator for all documents and process change orders. Utilize latest ETQ eQMS systems to facilitate/manage changes. Review submitted change orders for completion and work with other departments as required to ensure timely review of changes. Organize and run Change Control Meetings and manage meeting action items.

• Ensure that all employees are familiar with and follow document control procedures and good documentation practices. Perform training on these activities for new employees.

• Control and maintain current version of Device Master Records released for production

• Organize and store quality records, enabling timely retrieval when necessary. Perform, control and develop records archiving processes. Transition QMS records from legacy processes to ETQ eQMS software.

• Create and revise company documents as requested.

• Stay abreast of new regulatory procedures, guidance documents, and standards. Manage external document listing and the process for changes to those documents.

• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA, Customer, etc.)

• Participate in the Internal Quality Audit program and conduct audits as needed

• Perform system administration of ETQ eQMS software. Manage and train all personnel on ETQ eQMS document control application

• Lead eQMS training process and scheduling. Monitor and maintain the overall effectiveness of the training program

• Other duties as assigned

Requirements:

• Bachelor’s Degree or equivalent

• Minimum 1-year medical device experience; or equivalent combination of education and experience

• Knowledge of device standards and regulations such as ISO 13485, FDA Quality System Regulation, EU Medical Device Regulations, Canadian Medical Device Regulations

• Language Skills: Ability to read, analyze and interpret common business documents. Ability to communicate clearly to personnel in other departments. Ability to write well. Ability to effectively present information to colleagues and management.

• Excellent knowledge of Microsoft Office applications such as Word, Excel, Power Point, Visio as well as professional document control systems (ETQ)

• Organized, detail-oriented, and able to multi-task and prioritize responsibilities

• Experience in engineering and manufacturing environments preferred

• Experience in quality audits preferred

• Experience working with eQMS software preferred

• Detail oriented and ability to accurately and effectively process a large amount of documentation with minimal errors

For further information or to apply:
If you are interested in learning more about this opportunity and would like to apply; please forward resume to: Allison.hatfield@elosmedtech.com

Welcome with your application!

You can read more about us on our website: www.elosmedtech.com