Document Control Specialist

Job Summary:

Document Control manages and maintaining all documents in relations to Quality Management System

and manufacturing practices for medical devices. This position ensures that all documents are stored

properly, up to date, accurate, and released on a timely manner.

Essential Duties and Responsibilities (but are not limited to):

•  Assist with Document Management System activities in Grand Avenue Software.
•  Review, and approve Documentation Change Requests.
•  Prioritize Documentation Change Requests based on various project needs.
•  Review, upload, and maintain records such as DHR records, training records, supplier records,
• calibration records, etc.
•  Maintain Quality System Records.
•  Recommend updates to quality documentation or specifications as needed.
•  Provide documentation support for internal and external audits as requested by the auditor or
• Supervisor.

General

• • Identify and diagnose problems and follow through to resolution.
  • Participate as a team member by assisting others and by receiving and giving day to day
• feedback to ensure the achievement of quality results.
• • Perform other task as assigned or as required to function as member of a work team.
• Conceptual Skills:
• • Ability to manage and prioritize multiple tasks and remain focused on personal objectives.
  • High attention to detail and accuracy.
  • Dependable with a Positive, flexible outlook.
  • Strong interpersonal communication skills with the ability to effectively communicate across all
• levels.
• • Proven ability to work effectively independently and in a multi-disciplinary team.
  • Creative problem solver coupled with good judgment.

Education/Experience:

• • High School diploma or equivalent, college degree preferred.
  • Prior experience with Grand Avenue Software preferred.
  • Minimum of three years of medical device or other highly regulated environment.
  • Minimum of two years’ experience with quality system documentation and electronic systems.

This job description is intended to describe the general nature and level of work being performed by

employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills

required of employees in this position.