Document Control Specialist in Mesa, AZ at Volt

Date Posted: 10/10/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Mesa, AZ
  • Duration:
    16 weeks
  • Date Posted:
    10/10/2018
  • Job ID:
    141497
  • Pay Rate
    $0.0 - $14.0/Hour
  • Contact Name
    Volt Branch
  • Phone
    480-448-4280

Job Description

Job Summary:

Support the following Quality Assurance functions: document control, change control, CAPA, QC Inspection, auditing, and other functions as assigned.

Essential Functions:

Support document control and change system including: review and verify change orders for completeness, revise and upload supporting documents into database, route and track change orders, set up new user accounts and provide training and instruction as needed, monitor self training timeliness and escalate reminders as needed, track and trend related metrics and generate reports as needed.
Support nonconforming materials and CAPA process activities as needed.
Support inspection of incoming and finished goods materials as needed.
Support performance of internal QMS audits and response to 3rd party audits such as notified body or FDA audits as needed.
Support development of internal methods and procedures as needed.
Support and perform GMP training as needed.

Skills/Qualifications/Competencies:

Experience in a regulated industry, preferably medical devices.
Experience or knowledge of ISO 13485 and FDA requirements.
Excellent organization and communication skills.
Ability to work independently and in a team environment.
Proficiency with common software (E.g. Microsoft Office) and ability to quickly become proficient with new software.
Demonstrated problem solving and root cause analysis skills.
Good technical writing skills.