Job Number: 20014386

Location: Waukegan, IL

Date Posted: 4-11-2017

Job Title: Senior Quality Engineer - Medical Devices

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What Quality Engineering contributes to Cardinal Health

Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services.

  • Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
  • Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
  • Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.
  • Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
  • Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
  • Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
  • Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.


  • Strong working knowledge of Design control in a FDA regulated industry
  • Require GMP (21CFR820) and ISO 13485 knowledge and experience
  • Statistical knowledge including sampling plans, control charts, DOE, ANOVA etc.
  • Excellent interpersonal skills, self-starter and self-motivated
  • Excellent technical writing skills with CE marking knowledge preferred.
  • Bachelor’s degree in Engineering required.
  • ASQ Certification required, such as CQE, CMQ/OE, CQA/CBA.
  • Minimum 5 years of experience in medical device industry.
  • Ability to perform internal and external quality audits required.
  • Prior experience in supplier management – Contract manufacturers preferred.
  • Experience in data mining, trend analysis and presentation preferred

What is expected of you and others at this level

  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
  • May contribute to the development of policies and procedures
  • Works on complex projects of large scope
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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