Job Title: Principal Engineer, Quality
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CareFusion Business Description
The V. Mueller business provides surgical instruments which include a broad range of general, micro, long, specialty and custom-made instrumentation for surgical specialties such as cardiovascular, urology, gynecology, bariatrics, neurology orthopedic, spine, thoracic, ophthalmology, ENT and plastics.
Supplier Management: perform supplier evaluations; manage supplier changes and overall supplier quality.
Manage Engineering changes working with cross-functional team to ensure timely execution.
Product, process and Equipment Validation
Manage Corrective and Preventive Action System ensuring all Investigations are completed on time.
Plan, prioritize, set goals and manage multiple projects in a technical and business environment
Actively participate in continuous improvement efforts
Perform root cause analysis of quality issues
Recommend and implement cost effective permanent corrective actions
Assist production with problem solving and developing standardized work for production operators, including boundary samples
Strong communication skills to support meetings at all levels of the company, including senior leadership
Exhibit a willingness to do things differently and consistently translate ideas into actions that deliver results
Strong interpersonal skills with ability to work in a team environment
Job Family Summary
Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
What is expected of you for success in your role
Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
Demonstrates intermediate knowledge of FDA/ISO requirements
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
May act as mentor to less experienced team members
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Bachelor's degree strongly recommended
Advanced degree preferred
4-6 years experience
CareFusion Corporation - 18 months ago