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Sr Engineer, Quality Assurance

Req # JR - 152245 Location Hayward, California, United States Job Category Engineering Date posted 11/06/2024
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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 Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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

Sr Engineer, Quality Assurance

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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. 

Essential Duties and Responsibilities

  • Support batch release through root cause analysis, investigation and process optimization.
  • Conduct nonconformance and CAPA investigations with use of problem-solving techniques and technical writing skills.
  • Supports the manufacturing plant through implementation of process improvements.
  • Lead small projects (both new and improvement) to include cost, implementation, and validation.
  • Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
  • Composes protocols, final reports, studies, experiments, and general information reports for use by management.
  • Assist in evaluation of customer complaints, risk management and technical summaries.
  • Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485:2016, and other applicable standards and regulations.
  • Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
  • Responsible for:
    • Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
    • Identifying problems relating to the product, process and quality system.
    • Initiating and implementing solutions through designated channels.
    • Establishing controls on a process and establishment of the verification/monitoring of such.
    • Driving improvements into the production process, from conception to sustainable production methods.

Qualifications

  • Strong technical writing and investigation skills required.
  • Working knowledge of applicable standards and regulations: Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820) and ISO 13485:2016.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.
  • Familiarity with MINITAB preferred.

Education and/or Experience

  • Bachelor's Degree required in Engineering.
  • 3-5 years’ experience in Quality a pharmaceutical or medical device organization or a similar regulated industry. Other relevant experience outside of Quality but in a regulated industry may be considered.
  • Experience in manufacturing, particularly with a focus on adhering to relevant medical device regulations (21CFR820, 1SO13485, CMDR, MOD), is highly desirable.

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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Address

Explore this location 21026 Alexander Court
Hayward, CA 94545
United States of America
Explore This Location

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.”

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