Principal Engineer, Supplier Quality

JOB TITLE:          Principal Engineer, Supplier Quality

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

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.

    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

    Accountabilities

  • Oversee multiple contract manufacturers and private label suppliers of medical device products
  • Manage implementation of design changes and project development for medical devices
  • Work with suppliers on complaint investigations and address quality issues
  • Conduct supplier audits
  • Issue and follow up on supplier corrective actions

    Work Location

  • Dublin, Ireland

    Qualifications

  • Bachelor’s degree required, in related field, preferably in Engineering or technical fields
  • 4+ years of experience in supplier quality, preferred
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and / or Lead Assessor Certification preferred
  • Medical device quality experience, preferred
  • Working knowledge of ISO 13485 Medical Device Quality System Standard including European Medical Device Directive (MDD) Compliance Agreement and/or FDA Quality System Regulations, preferred