Full Job Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
The Senior Quality Engineer displays a basic understanding of the Product Engineering and Quality Management System concepts. Under the direction of a supervisor, this person is responsible for following Baxter quality policies to sustain product quality and ensure compliance. He/she utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quality Reviewer, he/she performs document reviews to support design and labeling change controls. With the help of a supervisor, this role formulates and recommends engineering technical work and contributes to 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, Design of Experiments, Molding, etc.)
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.
Provides support for New Product Development and guides team through the development process to ensure compliance to quality systems.
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 preferred. 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
At least three years of engineering experience with a bachelor’s degree in engineering required.
Prior experience in product development, design and/or testing within medical device industry.
Experience with disposable devices preferred.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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.