Quality Assurance Specialist – Document Control

Department

Quality Assurance

Location

San Diego, California

Job Type

Full Time

ID #

1234556


Cue is seeking to hire a full-time Quality Assurance SpecialistDocument Control.  This individual will maintain and facilitate the Change Order System and Document Control System.

Responsibilities:

  • Responsible for collection, maintenance, and storage of quality system and medical device product records including Device History Records (DHR), manuals, procedures, work instructions, forms, Design History File (DHF) and Device Master Records (DMRs)·      
  • Monitor and maintain the calibrations and preventive maintenance system, environmental control, and training program
  • Provide support to maintain the Quality Management System in accordance with US FDA Quality System Regulation, ISO 13485 and IVDD
  • Support incoming, in process and final QC inspections and QA release
  • Design and update labels and labeling
  • Assist in audits and publish audit reports (Internal and External)
  • Assist in the CAPAs, NCRs, Complaints, & Audits Systems
  • Provide administrative support within the Quality Assurance Department
  • Assist QA management with special projects

 


Requirements:

  • Knowledge in utilization of Microsoft Word, Access, Excel, internet applications and electronic quality management software system
  • Good understanding of cGMP (current Good Manufacturing Practices), ISO knowledge experience
  • 3+ years work experience in Quality Assurance Medical Device Field
  • Bachelor’s degree from four-year college or university
  • Analytical performance testing a plus
  • Ability to work in a fast-paced, dynamic, environment