Document Control Specialist

Description

Job Summary

Responsible for the accurate preparation, documentation, and distribution of all Quality System documentation, labeling and records.

Essential Job Functions

• Ensure documents and records meet company and regulatory standards
• Ensure compliance to internal QMS documentation and FDA CFR 820, and ISO 13485 as required.
• Maintain a computer database of all filed documentation that ensures fast retrieval of documents
• Maintain the flow of both electronic and hard-copied controlled documents, department files and resource materials
• Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
• Maintain archiving all Device History Records (DHR) and facility records
• Review change orders for completeness and accuracy
• Edit and assist in drafting new Quality System Procedures
• Support the Quality Department objectives and goals by participating in Quality projects when needed
• Assist with CAPAs as required

Qualifications

Required:

• Minimum 2 years working in Document Control within a Medical Device Quality Management System
• Minimum 1 year of experience working with metrics/data analytics
• High school diploma required, Associate’s degree preferred or equivalent appropriate industry experience

Preferred:

• ISO 13485 experience
• FDA regulated medical device experience 21CFR820, 21CFR210

Requirements

Competencies

• Ability to perform word processing and create basic spreadsheets, as well as work in Adobe and numerous on-line media
• Ability and willingness to learn/ use new software programs
• Ability to communicate effectively (both written and verbal)
• A high attention to detail and orderly focus
• Background in editing or documentation management
• Can follow instructions
• Will be a pro-active problem solver
• Work to maintain efficiency and quality balance in your work
• Team player (work cross functionally to support other departments)
• Good communicator

Physical Requirements

Performing the duties of this job regularly involves: (1) sitting, (2) standing; (3) walking; (4) hearing/listening (5) repetitive hand movement; (6) grasping; (7) reaching; (8) lifting; (9) carrying; (10) bending/stooping; (11) vision requirements - close vision, adjust focus, color code; (12) other.   

Mental Requirements

This position requires the ability to: (1) maintain an appropriate work pace; (2) comprehend and follow instructions; (3) exercise logic and reasoning; (4) organize and prioritize; (5) read; (6) compose written communication; (7) communicate verbally; (8) problem solve (9) make decisions; (10) count and compute (11) analyze and interpret data; (12) multi-task/re-direct; (13) experience numerous interruptions, (14) This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations; (15) other

Other Requirements

Minimal travel (less than 10%)

Work Environment

The noise level in the work environment is usually quiet to moderate.