Posted on Monday, October 20, 2008
Principal Engineer, Quality (08006074) - Cardinal Health

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

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 suggests process improvements based on observations.
• 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 implications to help guide team(s) through change.

Accountabilities in this role

• Maintains and assures compliance with appropriate regulations/standards relative to medical device design, engineering, manufacturing and distribution.
• Establishes and/or improves product/process quality individually and through Focused Factory Team base problem solving efforts using Respiratory Care Total 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

• BA/BS degree in Mechanical Engineering and 3 years of industry experience as a Quality Engineer. Or A.S Degree in Mechanical Engineering and 7 years of industry experience as a Quality Engineer. Or 10 Years of medical device industry experience as a Quality Engineer.
• Advanced degree preferred
• 4 -6 years applied experience
• Knowledge of FDA regulations, Quality Control and Documentation
• Proficient with MS Word, Excel and Access.
  

Please visit our job board at www.cardinalhealth.com/careers enter 08006074 in the "Keyword/Job Number" field