Documentation Systems Coordinator

Documentation Systems Coordinator

SUMMARY

Working with our Engineering and Quality Departments, this individual will be creating change orders, revising existing documentation, inspecting and post-approving artwork, and documentation associated with label changes to our product packaging.

This position supports one or more mid to senior-level managers and works in a diverse and complex environment inclusive of some customer and executive contact.

This role creates red line documents and enters into the AGILE Document Control Program and routing for approval.

Duties may include more complex administrative activities including managing project tasks, composing letters and reports, preparing / editing presentations, critical thinking / investigative skills, and recommending or making purchase decisions are included in the responsibilities of this role.

This role is responsible for the comparison of approved graphics to vendor proof's and the review / comparison of graphic files to technical documentation as defined by the Documentation Center.

Skills : Essential Functions

Attention to detail including Graphic, Alpha and Numeric.

Manage and track Graphics and their approvals.

Edit and revise Tech. Spec. using Word, Excel and AGILE.

Manage and track revised spec. and their approvals.

Organize and maintain work flow to establish priorities.

Possesses strong written and verbal communication skills. Intermediate to advanced computer skills including word processing, spreadsheet, and basic presentation or database applications and may train others.

Must be able to work autonomous with limited direction.

Preferred Skills / Qualifications :

Experience using Microsoft Office Software Skills / Competencies Ability to express ideas both in written and oral communications.

Education :

Education required High School Diploma

Preferred Associates Degree from a two-year college or technical school or equivalent experience. Experience Three years of experience preferably in a medical manufacturing industry.

Understanding of FDA regulations surrounding the manufacture of medical devices and GMPs ???????