Job Title: Senior Supplier Quality Engineer
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CareFusion Business Description
Our family of ventilation devices, including brands like AVEA® and Pulmonetic Systems™, offers customers leading edge products that range from adult to neonatal ventilators for all patient care areas. We also offer SensorMedics® diagnostic systems and Jaeger cardiopulmonary diagnostic products to help facilitate early diagnoses of chest diseases and sleep disorders. And, our patient care portfolio, including the market-leading AirLife™ brand and products from our strategic focus partners, is one of the most comprehensive lines of consumable products and small capital items available in the Respiratory marketplace.
This position will be primarily responsible for the supplier quality aspects of the components and services used in the products manufactured in the CareFusion Palm Springs facility. The position requires experience in quality engineering as it relates to manufacturing processes and supplier quality. At the Senior Quality Engineer level a working knowledge of quality engineering principles and best practices, as well as FDA and ISO regulations and requirements, is expected. The ability to work with a moderate amount of guidance from the manager or a Principle Quality engineer is expected of this position.
Supplier Quality, FDA, ISO
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 working knowledge of quality engineering policies, principles and best practices
Demonstrates working knowledge of FDA/ISO requirements
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
Applies working understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with minimal 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
2-4 years of experience
Experience in respiratory care or with the manufacture of electromechanical devices is desirable.
CareFusion Corporation - 21 months ago
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