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Job Title: Quality Engineer
Job Family Group (Function): Quality & Regulatory Affairs
CareFusion Business Description
Our Alaris® infusion products have helped safeguard patients from harm from adverse drug events. The Alaris® System, the world's first "smart IV pump," is the only modular platform that allows caregivers to standardize all infusion modalities on one flexible platform, maximizing clinical efficiencies while minimizing the potential for medication errors. http://www.carefusion.com/medical-products/infusion/iv-sets-accessories/
Participate in the Quality operations at a business unit level.
Direct activities in support of manufacturing to assure regulatory compliance.
Oversee validations to ensure proper execution (Installation Qualifications/Operational Qualifications/Process Qualifications).
Provide opinion and direction for setting validation strategy and structure.
Evaluate Engineering tests in support of validation or investigational studies.
Interface with engineering to introduce changes in process or product.
Ensure that quality inspection plans are appropriate for the product & process. Develop new plans as needed.
Ensure all elements of the quality system as they apply to operations are in compliance; CAPA, Training, Documentation, Calibration, Environmental.
Write, review and approve procedures that apply to Quality operations.
Participate in the internal audit program.
Participate in Operational Excellence programs.
Interface with customer audits, registration bodies and FDA auditors as needed.
Champion other activities within the organization as deemed necessary and appropriate.
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 basic knowledge of quality engineering policies, principles and best practices
Demonstrates basic knowledge of FDA/ISO requirements
Applies basic statistical sample size calculations to work for quality determination on simple projects
Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Bachelor's degree preferred - preferably in a Mechanical or Industrial Engineering discipline
0-2 years experience
Strong verbal and written skills
Experience with high volume, high cavitation plastic injection molding and/or liquid injection molding.
Six Sigma Green Belt
Experience with failure investigations/root cause analysis
CareFusion Corporation - 21 months ago