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Senior Principal Quality Engineer (Post Market)

What is expected of you at this level:


This senior level position is expected to lead and support key quality efforts within the CAH Patient Care Businesses.? They will coordinate the investigation of post market quality and patient safety ?issues, ensure alignment with functional groups, analyze post market data for adverse trends, ?and lead the ??corrective action process.


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

Accountabilities:

  • 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
  • Lead?Corrective Action and Preventive Action?(CAPA) activities
  • Collaborate/interface with medical safety,,, Marketing, Regulatory Affairs, and R&D, ?on ?corrective action plans. Interface directly with customers on issues, as needed

Qualifications:

  • B.S. in Technical discipline or equivalent experience is ?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,? automotive, aerospace or ?other regulated discipline preferred
  • Demonstrated CRITICAL THINKING skills with focus on improved product performance outcomes and positive business impact
  • Strong problem solving skills; Experience and success managing CAPA projects and working with multi-disciplinary teams
  • Exposure to or experience working in or with Design, Quality, Development Engineering, Clinical Affairs, and Manufacturing
  • Working knowledge of electro mechanical devices, Software hazanrd analysis, and.or plastics related manufacturing processes (i.e. injection molding, extrusion, automated and manual assemblies, etc)
  • Proven ability to work in a matrixed environment
  • Working knowledge of reliability studies including product performance modeling and trending.

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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