Principal Quality Engineer
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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.
Your Role at Baxter
The Principal Engineer will provide Quality Leadership for Monitoring and Sensing products both New Product Development (NPD) and post market support. You will apply diversified knowledge of engineering and quality principles to ensure compliance to medical device regulations and continuously improve product performance.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
What you'll be doing
- Responsible for implementing Baxter quality policies by partnering with Commercial, R&D, Regulatory, and other functions to develop and execute Quality strategies aligned with product development, change control, and post market initiatives.
- Plans, schedules, and leads multi-functional team in detailed phases of the Quality work on project initiatives.
- Analyzes data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints, Maude) to drive decisions.
- Develops product coding and establishes thresholds for product post market surveillance systems.
- Serves as a mentor, trainer & supports development of more junior associates.
- Supports Quality internal and external audits. Serves as an internal auditor if required.
What you'll bring
- Bachelor's degree in engineering is required.
- Master's degree is preferred.
- 5+ years of proven experience in Quality Engineering.
- A solid understanding of US Code of Federal Regulations, EU regulations, and ISO standards.
- Critical thinking skills in the application of Quality Management System concepts with a focus on executing design control across the Product Development Lifecycle.
- Ability to navigate in an abstract development environment applying agile development methodologies to advance quality deliverables concurrent with design maturity.
- Experience working with multi-functional teams, including technical/non-technical work.
- Proven leadership skills and ability to work independently.
- Ability to organize and present technical information with minimal assistance.
- Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.
- Strong oral and written communication skills.
#LI-BB1
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .
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