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Design Quality Engineer (Medical Devices)

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 process and procedures, which include project planning , design control, risk management, acceptance sampling and measurement systems.
  • Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, systems design, assessment tools and reporting.
  • Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions

Accountabilities

  • Lead support for new product development and product design changes for complex medical devices
  • Work cross divisional with Operations Quality, Research & Development , Medical Affairs, Regulatory Affairs, Marketing, and others to ensure design documentation for medical device products align with FDA 21CFR Part 820 and ISO 13485 regulations.
  • Ability to define product risks (hazards and hazardous situations) associated with product design and intended application(s).? ?
  • Demonstrated ability to quantify defined risks and create a risk assessment report linking risk with potential patient harm and define expected or tolerable levels of risk.
  • 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 to assure a sound product development plan is created and will lead to optimized product quality performance and compliant to internal and external standards
  • 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, Department of Defense (D.O.D.), or similar regulated industry is strongly 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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