In this position, the incumbent should display a basic understanding of the Product Engineering and Quality Management System concepts. Under the direction of a supervisor, this person will be responsible for following Baxter quality policies to sustain product quality and ensure compliance. He/she will utilize sound statistical and engineering techniques/tools to approach and solve problems. As Quality Reviewer, he/she will perform document reviews to support new product development from concept through launch. With the help of a supervisor, this role formulates and recommends engineering technical work and contributes to new product development, verification/validation activities, and design changes or enhancement of products and processes, in accordance with business objectives. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
1) Utilizes engineering product development/process knowledge to solve straight forward problems.
2) Performs standard engineering assignments to support new product development and assists cross-functional teams in identification of risks. Provides Quality Assurance support and guidance for verification and validation of product requirements. Supports reviews of product testing to ensure product conformance to specifications.
3) Provides support for New Product Development and guides team through the development process to ensure compliance to quality systems. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
BS in Engineering. 2 - 5 years experience.
Experience with electro-mechanical medical devices and working knowledge of medical device international standards preferred