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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