Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Quality Specialist

Job Code: #584
Job Type: Contract To Hire
Salary: $30.00 - $35.00/hour
Job Location: Mundelein, IL
Posted 2 weeks ago

Job Description

Job Title:  Quality Specialist

Pay:  $30.00 - $35.00/hour

Position Summary: 
Support the Quality Assurance team and Quality Management Representative with effectively managing the Total Quality Process, which requires a very strong focus on the overall Quality Process.  Responsible for identifying key process and product performance and quality issues for our products, and then works cross-functionally to continuously improve each key quality parameter.  Assure compliance with all FDA, GMP, ISO, OSHA and similar regulatory and quality requirements.

Essential Duties and Responsibilities:

  • Performs general quality system support for product production. This includes coordinating site product release and other quality system support functions as needed.  Assists manufacturing in completing deviation or non-conformance reports when product/process issues are identified.
  • Supports customer complaint investigations with guidance from QA Manager.
  • Performs day to day quality final product release. Checks product quality; looks for defects, signs off on lot specific manufacturing documentation.
  • Facilitates CAPA (Corrective Action Preventive Action) initiation, tracking, and closure activities.
  • Processes Product Design Transfer and Design Changes initiated by the company and associated tracking activities.
  • Maintains Device Master Records (DMR) and supporting documentation.
  • Maintains Device Master Records (DMR) and Supports Document Control processing and Training Impact Assessment activities.
  • Fosters an environment of continuous quality management improvement.
  • BS in Science preferred.
  • Minimum of 2-4 years of Quality Assurance experience in Medical Device.
  • Previous experience with CAPA.
  • Experience with product release.
  • Working with non-conformance reports.
  • Experience supporting Quality Systems.