Document Control Specialist Job Descriptions, Average Salary, Interview Questions

Duties and responsibilities

• Performs administrative duties in support of the Documentation department in an ISO/AS environment
• Prepare documentation packet for approval, as well as distribute for approval and release into the system
• Maintain the drawing portal, release/update drawing into the ERP (MAS)
• Maintaining the training system when training is identified in the document release process
• Work with the Manager to ensure documented information is maintained and preserved from damage
• Work with Service Provider to archive/retrieve documented information stored off-site

Qualifications

• Proficient in general computer and documentation skills
• Excellent command of written English
• Good communication skills
• Excellent knowledge of general office equipment and skills especially filing and typing
• The ability to understand general engineering documents is a plus
• Organized work habits and the ability to multi-task required

Education

• Associate degree in a related field
• 2-5 years of related job experience

The Document Control Specialist is a crucial contributor to the success of department projects. The Document Control Specialist will be responsible for maintaining an organized and detailed library of project documentation primarily using ProjectWise. The Document Controls Specialist will be responsible for the administration and control of documents that are received, created, or issued as part of a project in an engineering consulting environment.

What you’ll do

• Maintains, organizes, and updates documents in electronic drawing management systems. Familiarity with ProjectWise required; AutoDesk Vault, BIM 360, and SharePoint preferred
• Provides on-time and on-budget, complete administrative and analytical support in relation to engineering document services
• Demonstrates adherence to client-driven engineering document services policies, procedures, standards, and guidelines
• Provides services for engineering document requests
• Communicates document requirements and client standards to the engineering team
• Performs collection, entry, and distribution procedures as required
• Ensures document transmittals by others are accurate and complete
• Utilizes interpersonal skills in maintaining balance with all party’s requirements and priorities
• Proactively communicates with client Document Control Specialists and internal teams to manage workload and project requests
• Contributes to the development of department policies including documentation, storage, and organization policies
• Initiates corrective action for continuous improvement of efficiency and customer service
• Performs quality assurance and quality control of engineering documents
• Performs periodic archiving and audits to maintain document repository standards
• Investigates compliance as necessary
• Support of engineering documents with verification of document accuracy through audits

What we expect from you

• High School Diploma or equivalent required. Associate degree or higher preferred
• 2 years of previous document control experience in an engineering, construction, or technical office preferred
• Demonstrated proficiency in analyzing data, problem identification and resolution, and ability to generate clear/concise reports indicating key issues
• Microsoft Office Applications Experience (i.e. Excel, Word, etc.)
• Strong communication and organization skills both verbal and written
• High attention to detail
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to work on multiple tasks and prioritize work
• Must be willing to work extended hours as necessary
• Ability to work cross-functionally as a team
• Must have the authorization to work permanently in the US

This position requires a hands-on individual contributor that is capable of working on and tracking a large number of tasks in a fast-paced environment, with minimal supervision. Additional responsibilities include assisting with other documentation writing (R&D documents, country registration documents, etc) such that documents are compliant, easy to use, and complete.

Duties and responsibilities

• Engineering document assembly, change control, and Document Control Library archival
• Maintenance and continuous improvement of the Change Control process
• Assists in the building of documents for regulatory submissions, as well as interfaces with customers as needed
• Daily interaction and documentation & compliance support to internal & external engineering, research & development, manufacturing operations, materials management, program management, and qualified individuals and groups
• Evaluation and retention of Batch Records and Device History Records for GMP compliance
• Administrator CAPA
• Write/update QMS Elements, procedures, processes, forms, and templates for R&D, Engineering, Manufacturing Operations, etc.
• Assists in the periodic inspection of manufacturing areas, to assure that they are operated and administered according to GMP and safety requirements
• Lead projects related to QA/QC efficiency and improvement
• Create, maintain and report on metrics for tracking and trending the performance of the QMS
• Support regulatory, customer, internal, and notified body audits
• Contribute to effort to transfer QMS from essentially a manual, shared drive configuration to a specialized medical device enterprise management system
• May perform notary activities if needed
• All additional duties as directed and required by quality/regulatory management

Qualifications, education, and experience

• Minimum of 1-year experience working as a technical writer, 3 years preferred
• Some experience or training in project leadership
• Knowledge of ISO and/or FDA quality system guidelines is preferred
• Some experience with a medical device company is desired
• Very strong PC skills. Proficient in MS Office applications
• Knowledge of SolidWorks or similar CAD application is preferred