Document Control Specialist

I. Summary of Position
This position is responsible for:
- Implement and adhere to document control procedures, including version control, document approval, and
archiving
- Create and Edit Documents: Prepare, format, and edit documentation related to product development, quality
assurance, and manufacturing processes.
- Coordinate Reviews: Facilitate the review and approval process for new or revised documents by
coordinating with relevant departments or stakeholders
- Assisting in the development and implementation of the Document Change Requests for the company’s-
controlled documentation.
- Assisting with the deployment of training materials to the company's employees and maintaining resulting
training records.
- Other Quality related functions that may be assigned
 

II. Primary Job Responsibilities
- Assist with the initiation and execution of Document Change Requests for the release of new or revised Controlled Documents with respective departmental personnel; maintain DCR and Document Master and
Locations specific files in accordance with established policies and procedures.
- Assist in drafting and reviewing new and revised documents, including but not limited to, policies, procedures, Work Instructions, and related Controlled Documents.
- Assist with the scheduling and execution of employee training with respective department / function
management by reviewing and maintaining training plans and records for new hires and current employees.
- Communicate with various departments to gather and disseminate information related to documentation
needs.
- Support Teams: Provide support to Quality Assurance, Regulatory Affairs, Engineering and Production
teams by ensuring that they have access to the necessary documentation
- Other duties as may be assigned by manager.

III. Qualifications
- Bachelor’s degree (B.A.) from four-year college or university; or two to five years related experience and/or
training in medical device manufacturing; or equivalent combination of education and experience.
- Possess working knowledge of US FDA Quality System Regulations.
- Self-starter capable of managing multiple projects at one time
- Good working computer skills; knowledge of MS Excel and Word.
 

IV. Travel and Other Physical Demands
- Travel of approximately 10%
V. Accountability (size of responsibility)
- Support the Regulatory Affairs and Quality Assurance functions / departments