Principal Engineer, Quality - Failure Analysis Laboratory
Cardinal Health
Juarez, Chihuahua
hace 2 horas

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.
  • Qualifications

  • 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.

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