Principal Engineer, Quality

JOB TITLE: Principle Engineer, Quality



Every day at CareFusion, we work to improve patient care. By combining clinically proven products and services with actionable intelligence, we're helping to solve some of healthcare's most difficult challenges. Join us.



Function: QRA

Family: Quality Engineering





What Quality Engineering contributes to Cardinal Health








What is expected of you and others at this level in Quality & Regulatory Affairs for functional success

• Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces


• Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.


• Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.


• Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.


• Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity

Accountabilities in this role


 Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
 
·        Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams.
 
·        Responsible for coordinating process improvement efforts regarding production failures.
 
·        Responsible for overseeing failure analysis, documenting failure analysis and recommending corrective action for instrument complaint, service, production and receiving inspections issues.
 
·        Support  Development/Operations Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action for products.
 
·        Responsible for reviewing NCMRs to verify discrepancy and adequacy of response to corrective action request.
 
·        Reviews and approves test and validation documents and Change Orders for product  and process changes.
 
·        Reviews and approves receiving inspection requirements and sampling plans for components.
 
·        Initiates Change Orders   to correct drawings and specifications and Quality System Procedures.
 
·        Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation.
 
·        Initiates and manages projects to improve the Quality Systems and compliance.




Qualifications

• Bachelor's degree strongly recommended


• Advanced degree preferred


• 4-6 years experience