Sr Engineer, Quality Assurance
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
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.
Address
Hayward, CA 94545
United States of America Explore This Location
Related Content
-
March 05, 2024
-
Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. March 28, 2024
-
People of Baxter The people of Baxter are men and women who make a difference at work and in their communities. March 28, 2024
-
March 05, 2024
-
March 05, 2024
-
How to Apply Learn tips to better prepare yourself for the application process. March 05, 2024 Related Content - SR_JD
-
March 05, 2024
-
March 05, 2024
-
June 14, 2024
-
June 14, 2024
-
June 05, 2024
-
May 07, 2024
-
Change Creates Opportunity We believe change provides the opportunity to push beyond what we thought we were capable of achieving. April 29, 2024
-
July 11, 2024
-
May 31, 2024
-
May 01, 2024
-
Meet Mike Hear from Mike Demirjian on how change is necessary for growth, innovation, and improvement. May 01, 2024
-
May 08, 2024
-
July 15, 2024
-
July 14, 2024
-
July 09, 2024
-
July 15, 2024
-
May 08, 2024
-
July 15, 2024
-
May 01, 2024
-
May 07, 2024
-
July 14, 2024
-
July 14, 2024
-
July 12, 2024
-
July 11, 2024
-
July 10, 2024
-
July 12, 2024
-
July 12, 2024
-
July 11, 2024
-
April 29, 2024
-
July 11, 2024
-
July 15, 2024
-
July 14, 2024
-
July 13, 2024
-
July 13, 2024
-
July 13, 2024
-
July 09, 2024
-
July 10, 2024
-
July 09, 2024
-
Our Proposed Separation We plan to separate our Kidney Care Global Business Segment from Baxter to become a separate company. Discover what this means for you. May 03, 2024 Related Content - SR_JD
-
May 23, 2024
-
July 11, 2024
-
Meet Yukinari Yukinari Kono believes a leader should instill confidence and optimism in his teams during times of transformation. May 08, 2024
-
Career Areas Explore our various career sectors and uncover the one that aligns best with your talents and professional goals. March 05, 2024 Related Content - SR_JD
-
October 21, 2024
-
September 05, 2024
Join Our Talent Community
We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.