The Design Quality Assurance Engineer (NPD/NBD Quality Engineer) works on design quality assurance activities related to new product development and new business development, ensuring compliance with regulatory and company requirements.
Qualified candidates should have the following Quality Engineering skills:
Applies knowledge of engineering and/or scientific principles, theories, and practices in areas of assignments, plus a working knowledge of other related disciplines.
Demonstrates ability to identify problems as well as determine and develop approaches to solutions on problems, using engineering and/or scientific principles as well as quality principles, including root cause analysis and corrective and preventative actions.
Demonstrates understanding and application of statistical techniques, quantitative and qualitative, to facilitate design and process analysis, including improvements.
Demonstrates understanding and/or application of Design Controls, Process Validation, Risk Management, and Change Control.
Ensures appropriate engineering and scientific analyses are employed.
The ideal candidate should have:
Minimum B.S. in Engineering, preferably Mechanical, Material Science, or Biomedical
Supplier Quality Engineering experience is also a plus, which includes experience with Supplier Quality Agreements and Component qualifications
Excellent attention to detail
What Quality Engineering contributes to Cordis
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
About Cordis, a Cardinal Health Company
Cordis is a worldwide leader in the development and manufacture of interventional vascular technology with a more than 50-year history of delivering pioneering products to treat millions of patients. With a reputation for clinical acumen, training and services, Cordis established a legacy of innovation in high-quality and less-invasive cardiovascular products and built a strong global footprint with operations in countries around the world.