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Summary:

Display basic understanding of the Product Engineering and Quality Management System concepts. Under direction of supervisor, is responsible for following Baxter quality policies to sustain product quality and ensure compliance. Conducts complaint analysis. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quality Reviewer performs document reviews to support design and labeling change controls. With supervisor, formulates and recommends engineering technical work, contributes to the design changes or enhancement of products and processes, in accordance with business objectives.

Essential Duties and Responsibilities:

• Utilizes DMAIC tools to investigate non-conformances and participates in (CAPA)-related activities, including CAPA ownership.
• Utilizes engineering product development/process knowledge to solve straight forward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Molding, SPC)
• Performs standard engineering assignments to support change controls and assists cross-functional teams in identification of risks. Supports product testing to ensure product conformance to specifications.
• Understands principles of complaint handling process and supports complaint investigations.
• Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions. Facilitates small project teams as needed to accomplish team objectives. Supports Quality internal and external audits as required.

Qualifications:

• Display basic understanding of Quality Management System and GMP.
• Display a technical understanding of engineering and product development principles and procedures.
• Possess basic understanding of statistical process controls (SPC), measurement systems analysis (MSA), and DMAIC investigation tools.
• Familiarity with Minitab required. Display basic understanding of change controls and risk management principles.
• Experience in working with cross-functional teams, including technical and non-technical work.
• Ability to organize and present technical information with minimal assistance.
• Demonstrates solid organizational skills and ability to work independently.

Background and/or Experience:

• BS in Engineering and 3-5 years related engineering/science/quality experience. Preferred:
• Prior experience in product development, design and/or testing within medical device industry
• Experience with electromechanical devices

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.