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Principle Design Quality Engineer

What Design Quality Engineering contributes to Cardinal Health
Design 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.
Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, risk management, 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.
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.
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and project
Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.
Accountabilities
Lead support for new product development and product design changes for complex medical devices
Work cross divisionally with Quality Engineering, Research & Development Engineering, Regulatory Affairs, Marketing, and others to ensure documentation for medical device products align with FDA 21CFR Part 820 and ISO 13485 regulations.
Conduct risk assessment analysis, construct risk assessment charts and be accountable as a SME for risk management. Identifying potential non-performances in product and create/maintain a risk management file which includes risk management plan, hazard identification, risk assessment chart (RAC), master harms list, and risk management report.
Support the creation and review of design inputs, outputs and validation documentation per regulatory guidelines
Support post market activities as necessary such as Corrective and Preventive action projects related to identified design issues.
Follow and maintain quality system policies and procedures to ensure that products and processes meet applicable standards and specifications
Coordinate business meetings to communicate and align on product issues and ensure appropriate decision making is made to initiate actions or support documentation for no action require
Act as an objective reviewer to review the content of the document and ensure product development adheres to regulatory guidelines
Qualifications
B.S. in Engineering or associated scientific discipline, Required
6+ years' experience in Quality Engineering for Medical Device, strongly preferred
Working experience with IEC 61010 or IEC 60001 standards, preferred
Working knowledge of Risk Management Standards (ISO 14971) and Quality Medical Device Regulations (FDA 21CFR 820), preferred
Exposure to or working experience with New Product Design, Quality, Development Engineering, Clinical Affairs, and Medical Manufacturing procedures, preferred
ASQ Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) certification, preferred
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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