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.
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
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.