senior specialist quality control

What Quality Control contributes to Cardinal Health

Quality control is responsible for the analysis or inspection of products or processes for compliance with specifications and standards.

  • Demonstrates knowledge of FDA medical regulations, SOPs, and quality guidelines to include 510K, MDL, FDA product code classification, NDC, and UDI.
  • Communicates effectively with suppliers to compile & validate product’s required regulatory pathway. 
  • Completes applicable documentation needed for the release of product and inputs data.       
  • Adheres to established policies and procedures.
  • Demonstrates detail-oriented attention in all facets of responsibilities.
  • Works with minimal supervision, manages time effectively, and maintains control over all current responsibilities/projects. Follows up on all relevant issues.

Qualifications

  • Bachelor’s in related field, or equivalent work experience, preferred
  • 2+ years experience in related field, preferred
  • Strong Microsoft office and excel skills
  • Oracle Agile familiarity, preferred
  • Strong written and verbal communication skills
  • Ability to communicate within all levels of CAH regulatory organization including Sr leadership.
  • Ability to learn other computer systems and retain information.
  • Background with UDI, preferred
  • Strong sense of urgency, meets schedules and deadlines.
  • Familiar with FDA product code classification of medical devices, regulations, and registration requirements, highly preferred.
  • Regulatory background, preferred
  • Able to work with cross-functional team and departments

What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possbile solutions to a variety of technical problems and takes actions to resolve
  • Applies judgment within defined parameters
  • Receives general guidance may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy