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Senior Principal Quality Engineer (Post Market)

What is expected of you at this level:


This position is expected to lead and support key post market quality efforts within the CAH Patient Care Businesses.? They will coordinate the investigation of post market assessments, ensure alignment with functional groups, analyze post market data for adverse trends, Risk assessments, and deployment of corrective and preventive actions.


This role is focused on maintaining and improving process and product performance and monitoring. As such, this position is expected to:



  • Lead and support key product quality efforts within the Cardinal Health Patient Care Businesses.

  • Operate in a global corporate setting and? collaborate with all functions? to ensure the proper application, use and updates of risk management files following product launch

  • Review and analyze customer complaint data for trends or significant event to assure appropriate action is taken to address the issue.? Action can include initiate of CAPA or escalation of event to a Health Hazard Evaluation

  • Collaborate with all functions to ensure the proper application, use and updates of risk management files following product launch

  • Monitor Complaint trends within the Cardinal Health Patient Care to assess opportunities for improvement

  • Provide product risk assessment related to field issues and provide response to regulatory body inquiries as necessary

  • Drive continuous improvement through CAPA by leading, and collaborating with cross functional teams including Quality, R&D, Marketing, and Medical/Clinical Affairs

  • Create internal communications to support procedural and process requirements and reports for health agencies as required

  • Understand therapy and clinical performance, products, and product use environments to appropriately and strategically apply technical knowledge, tools and methodologies to drive product quality

  • Create and maintain documentation related to internal health risk assessments, agency reporting, Request for additional information (RFAI), and internal communications


Accountabilities:


This role supports a wide range of cross-functional teams including Sustaining Engineering and Manufacturing.? As such, this position is focused on maintaining the product integrity through performance monitoring and supporting/resolving quality issues that arise during post-production and use. Responsibilities include:



  • Statistically evaluate field performance, analyze field performance trends, and recommend corrective action when necessary

  • Follow and maintain quality system policies and procedures to ensure that products and processes meet applicable standards and specifications

  • Internal reporting and project tracking.

  • Lead?Corrective Action and Preventive Action?(CAPA) activities

  • Collaborate/interface with Clinical, Quality, Marketing, and Product Development on field corrective action plans. Interface directly with customers on issues, as needed


Qualifications:



  • B.S. in Engineering?or associated scientific discipline, Required

  • Working knowledge of? Risk Management Standards (ISO 14971)?and?Quality Medical Device Regulations?(FDA 21CFR 820, , ISO13485, and MDD), preferred

  • 8 years Medical Devices?experience in Quality or R&D Engineering position, preferred

  • Demonstrated CRITICAL THINKING skills with focus on improved product performance outcomes and positive business impact

  • Experience and success managing CAPA projects and working with multi-disciplinary teams

  • DFSS or DMAIC Black Belt Certified or Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred

  • Exposure to or experience working in or with Design, Quality, Development Engineering, Clinical Affairs, and Manufacturing


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.


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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