Principal 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.

 

 
What is expected of you and others at this level in Quality &
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 CareFusion; 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  

  • Maintains and assures compliance with appropriate regulations/standards relative to medical device design, engineering, and manufacturing.
  • Establishes and/or improves product/process quality individually and through team base problem solving efforts using Lean Six Sigma and other Quality tools.
  • Participates in the Material Review Board activities during process development of product and productions.  Evaluates nonconformance reports as required; coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of corrective actions.
  • Coordinates supplier corrective action activities with purchasing and other departments as necessary for supplier quality issues.
  • Ensures proper validation of installation quality, operation quality and performance quality of equipment, documentation, processes through review of validation plans and subsequent audit(s) of those activities at the supplier’s location.
  • Provides technical guidance for supplier improvement activities
  • Reviews and evaluates Engineering Change Request/ Engineering Change Order for accuracy, effectiveness and compliance and provide support to the component change control board process.
  • Performs audits on supplier manufacturing processes to assure compliance at subassembly and system levels.
  • Provides design input(s) related to the quality during the design and development phase. Performs appropriate analyses and evaluations, as needed, to make recommended changes

Qualifications

o                     Bachelor’s degree strongly recommended

o                      Advanced degree preferred

o                      4-6 years experience

Patrick Monteforte
Recruiter 

Talent Management - Staffing CareFusion
3750 Torrey View Court
San Diego , CA 92130

858.617.2272 direct

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