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Principal Quality Engineer

Req #: JR - 077274 Location Hayward, California, United States Job Category: Engineering Date Posted: 08/05/2022

Overview

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.

  • 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 Engineer at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Problem Solver
  • Analytical Thinker
  • Data Driven
  • Solution Focused & Results Oriented
  • Collaborative
  • Innovative

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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. 

This position is responsible for providing Quality support in process improvements, compliance projects and manufacturing support.  Identify and assess regulatory and quality risks in manufacturing activities and processes per regulatory agency guidelines and Baxter quality policies.

Responsibilities:

  • Lead continuous improvement projects focused on manufacturing and quality processes.
  • Perform data and statistical analysis.
  • Act as local Quality support on new product launch or geographic expansion initiatives.
  • Write, review, and approve validation/manufacturing protocols and reports, technical documents, etc.
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs), Batch Records, and other documents and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Lead and assist in non-conformance investigations.
  • Perform gap assessment on manufacturing and quality processes.
  • Support Change Control, NCR, CAPA, Management Review, Corporate Holds, Field Corrective Actions, or other quality systems, as assigned
  • Participate in multi-site Quality projects in the role of contributor, coordinator or lead.

Knowledge/Skills/Abilities:

  • Must be very detailed oriented with a high quality of work
  • Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
  • Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.
  • Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
  • Proficient in Microsoft Office applications (e.g. Word, Excel, etc)
  • Regular attendance is necessary to perform the essential functions of the job.
  • Light work, may require lifting; extended period of sitting/standing.
  • No travel required
  • Normal office working conditions: computer, phone, files, fax, copier.
  • Personal Protective Equipment: safety glasses as required

Education/Experience

  • BS in Engineering, Biological Sciences, or equivalent
  • 7-10 Years in Quality a pharmaceutical or medical device organization or a similarly regulated industry.
  • Must have experience in General Engineering, Quality Engineering, Validation, or another technical role.
  • Other relevant experience outside of Quality but in a regulated industry may be considered.
  • Industry experience with applicable medical device (21CFR820, ISO13485, CMDR, MDD) and/or biologics regulations desirable

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.

077274

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 Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an Engineering Technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

Quotes

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 Sarah – (center) with members of the Baxter Engineering team who initiated a corporate partnership with Society of Women Engineers.

“Initially I thought I would go to medical school and become a doctor, but I remember calling my mom sophomore year in college and saying ‘I’m going to miss my math.’ I realized at that moment that I preferred to be behind the scenes helping patients by making products that will save them..”

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an engineering technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

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