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Principal Quality Engineer

Req #: JR - 066671 Location Bellevue, Washington, United States Job Category: Quality Control Date Posted: 06/06/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Principal Quality Engineer

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. 

Do you want to use your Quality Engineering skills to make a difference in the world of cardiac monitoring and arrhythmia diagnosis? Bardy Diagnostics (BardyDx) is a high-growth business unit within Baxter with a unique and compelling product, looking for the right person to help us achieve our mission.

Join a talented cross-functional team commercializing a state-of-the art cardiac monitor and associated cloud-based software with an exciting product pipeline.

The right person will be energized by providing Quality leadership in the development and commercialization of BardyDx products, ensuring they meet the highest quality, safety, and performance standards. Come help us maintain our rapid growth trajectory while always keeping the patient first.

Duties and Responsibilities

  • Provide Quality Engineering leadership for software and hardware product development teams; responsible for leading design control, risk management, and quality engineering activities.
  • Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and the risk management report.
  • Provide quality engineering input, review, and approval of the Design History File (DHF); responsible for quality oversight of design plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports. Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
  • Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
  • Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
  • Own the resolution and timely closure of CAPAs as they relate to the design control process.
  • Support other areas of the Quality System and perform other tasks as defined by Management.

Minimum Qualifications/Education for this role

  • 10+ years of progressive Engineering experience in medical device and/or pharma/biotech industries, with 5+ years of hands-on quality engineering support for hardware and software development.
  • B.S./M.S. in relevant engineering field (e.g. biomedical, software, electrical, etc.) or equivalent scientific degree.
  • Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366. 
  • Experience in the design, development, verification, validation and testing activities for embedded software.
  • Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis.
  • Exceptional verbal and written communication skills and attention to detail with the proven ability to wear many hats.
  • Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for regulatory compliance.
  • Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
  • Experience developing artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.
  • Experience working within an AAMI TIR45 framework for the development of SaMD is preferred.
  • Certified SAFe scrum master, Six Sigma Black Belt/Green Belt, and/or ASQ CQE preferred.

#LI-BB1

#IND-USOPS

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.

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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.

066671

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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