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Principal 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 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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