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.
Essential Duties and Responsibilities :
Lead a small group of people as required and departmental projects with a high complexity to improve internal and / or organizational processes.
Responsible for assigning product complaint files and complaint activities to the appropriate product complaint analysts and FAL personnel as appropriate.
Investigates and processes product complaints, while maintaining compliance to all regulations
Performs / Document Product History Reviews and Product Evaluation properly and following GDP’s.
Maintain communication with Engineering teams in order to review deeply complaints that may be related to a manufacturing and / or design issue.
Devises new approaches to problems encountered and identifies process improvement opportunities.
Perform measuring, testing and analysis on the returned devices to determine the root causes of the issues presented. (e.
g. dimensional inspection with rule, caliper, laser micrometer, etc.; also, perform functional testing by using pull testers, leak testers, and other equipment as required)
Document the investigation in the applicable Global Complaint Handling System applicable, following Cordis Policies and procedures, and as well as required per applicable regulations.
May be required to perform specialized studies such SEM analysis, X-Ray analysis, and others analyses as applicable.
Address investigations to document Audit Observations, CAPA Actions, non-conformances, and any other investigation as applicable.
Comply with internal departmental metrics and with the Complaint Handling and Safety Surveillance departmental metrics.
Lead FAL Analysts and Participate in QA operation / Management meetings to present complaint trending analysis per area as applicable and required assuring presentations are performed properly.
Maintain appropriate level of knowledge on product and processes manufactured by the company and OEM’s as required, and perform any update required involving External manufacturers.
Escalate manufacturing and design issues related properly and in a timely manner to investigate further on the failure found and to allow the implementation of the corrective / preventive actions detected during investigations.
Leads lessons learned sessions internally and externally as applicable.
Presents departmental information to upper management when required.
Required to work in short and medium-term projects.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Maintain metrics updated as required assuring they comply based on internal requirements / goals.
Bachelors in related field, or equivalent work experience, preferred
4+ years experience in related field, preferred
Master's degree is desirable
Experience in managing people is desirable
Experience in the medical device industry would be an asset
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.