Document Control Coordinator

Document Control Coordinator

The corporate head quarters for medical equipment manufacturing company is looking for a Document Control Coordinator to join their office.  The ideal candidate will have great attention to detail and be capable of working in a fast paced environment.

Responsibilities Include:

Set-up and maintain electronic templates and forms to ensure consistency of documentation

Maintain device master records (DMR) files for all products

Maintain controlled documentation to current revision levels and process Document Changes (DCO?s) as required

Create and maintain logs to efficiently track status of agreed upon documents as well data entry into logs

Manage and control all Validation records

Decide required signatures for DCO?s and route for signatures among defined departments

File and maintain controlled electronic or hard copy of internal and customer supplied documents, drawings and specifications

Distribute current/revised documentation and collect obsolete documents and perform periodic audits of controlled document locations to ensure that correct versions are being used

Organize and prepare files for customer records management and archiving

Interface with management and group engineers as required and respond to soft copy or hard copy requests of all documents

Create Distribution Matrices, Logs, Procedures and Flow Charts for processing of specific documents.

Ensure compliance of the documentation control systems with company quality system policies and proceedures as required in a medical device environment and per relevant FDA QSR and ISO standards

Train employees with regard to aspects of document control

Complete special projects or other duties as required

 

Job Requirements:

-2-3 years of document control experience

-Medical knowledge/terminology preferred

-Medical Device Industry experience

-Excellent computer skills and knowledge of Oracle

-Strong attention to detail

-Associates or Bachelor's degree in a related field

 

This position will pay between $38,000 and $45,000 annually.  Please apply online for immediate consideration.  Only local candidates will be considered.