Quality System Specialist Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Clinical/Regulatory
The Quality System Specialist maintains the device Technical Files through completion of appropriate documentation in accordance with applicable standards and regulations.
Maintains device Technical Files within Master Control.
Completes and maintains Annex Checklists and Form 071.0, Part A, Guide to Technical Files.
Maintains organization of Technical File records.
Ensures completion of Design History Files and Device Master Records.
Reviews retention records for completeness (e.g. Operations Batch Sheets, Cell Culture Specification Sheets and Shipping Protocols).
Numbers, images, renames and uploads completed records into the record control system (e.g. Quality Control product stability testing information, training records, Customer Service files and quotes, Operations maintenance and calibration records, and equipment manuals)..
Assists DHI staff with retrieving information from the records control system when required.
Performs other duties as assigned.
Participates in the corrective and preventative action system (CAPA)
Reports directly to the Records Supervisor
Has no supervisory responsibilities.
Education and Training
High School Diploma or GED required.
One or two years previous work experience in related field.
Trained to PTC?s Windchill program (ProjectLink and PDMLink)
Must be proficient in the operation of EDMS (electronic document management system) resources.
Experience and Skills
The individual has excellent time management, and organizational skills.
The individual has superb customer service skills and is an expert communicator and facilitator, both written and oral.
The individual has acuity for attention to detail and focus on accuracy with excellent problem-solving skills.
The individual has the ability to work independently and manage multiple projects concurrently.
The individual is proficient with MS Office (Word, Excel, Power Point and Outlook).
Designation as an internal auditor preferred.
Normal office environment.
Lifts and carries 25 lbs. routinely.
||Athens, OH 00000 |
THIS JOB HAS EXPIRED