Job Title: Senior Engineer, Quality
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This position will be responsible for the quality aspects of the Factory Service organization in the CareFusion Palm Springs facility. The position requires experience in quality engineering as it relates to service and manufacturing processes. The Senior Quality Engineer requires a working knowledge of quality engineering principles and best practices, as well as knowledge of FDA and ISO regulations and requirements. The ability to work with a moderate amount of guidance from the manager or a Principle Quality engineer is expected of this position.
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 service and 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 experience
Experience in respiratory care or with the manufacture of electromechanical devices is desirable.
Experience or certification in Lean Six-Sigma highly desired