Documentation Specialist

JOB TITLE:   Documentation Control Specialist

 

GENERAL DESCRIPTIONS:

This position is responsible for overseeing all aspects of the Master Product and Technical Files.

 

JOB RESPONSIBLITIES:

This Position reports to the Manager of Quality Assurance and has primary responsibility for ensuring that the companies controlled documentation are in compliance with Internal, Federal and International regulatory requirements. 

 

Responsibilities include maintaining the Master Product Files and Technical Files.  Specific responsibilities include; updating and generating procedures and specifications, overseeing and implementing changes to and distribution of specifications through the ECO system, maintaining BOMs, final approval and release of all Lot and Device History records, final release DMR/TF Checklists, scheduling and preparation of Management Review Meetings, coordinating the implementation of corrective and preventative action activities, conducting QSR/ISO audits, maintenance of the product complaint/adverse event system, including periodic trend analysis, and other responsibilities as assigned. 

 

 

MINIMUM QUALIFICATIONS:

The incumbent must have a minimum of four years of related experience in a Class II or III medical device or pharmaceutical company.  Must have good written, verbal and interpersonal communication skills.  Must possess a strong understanding of word processing and data base software management (Word, Excel.)  Experience in Auto-Cad, Cad-Key and Corel Draw is a plus.

 

EDUCATION REQUIREMENTS:

Four year degree or equivalent.