Design Quality Principal Engineer

Cardinal Health Waukegan , IL 60079

Posted 4 months ago

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.

Qualifications

  • Requires a bachelor's degree in an Engineering discipline plus five years of progressive post-baccalaureate experience in the medical device industry or a Master's degree in an Engineering discipline plus three years of experience in the same.

  • Min of 2 years in Med Device Quality, preferred in a DQE role

  • Experience must include design control under FDA regulations and GMP

  • 21CFR Part 820; 21CFR Part 210 and 211

  • ISO 13485:2016; ISO 19011; ISO14971:2012

  • ICE 60601

  • Must have statistical knowledge of sampling plans and control charts; internal and external audit experience; and ASQ Certification such as CQE, CMQ/QE, or CQA/CBA.

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects

  • Participates in the development of policies and procedures to achieve specific goals

  • Recommends new practices, processes, metrics, or models

  • Works on or may lead complex projects of large scope

  • Projects may have significant and long-term impact

  • Provides solutions which may set precedent

  • Independently determines method for completion of new projects

  • Receives guidance on overall project objectives

  • Acts 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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Design Quality Principal Engineer

Cardinal Health