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Sr. Quality Engineer

Req #: JR - 023393 Location: Irvine, California, United States Job Category: Engineering Date Posted: 07/01/2020

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.


  • Schedule:
    Full Time


  • Job Level:
    Mid-Level

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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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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.”

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.”

Sr. Quality Engineer

Req # JR - 023393 Location Irvine, California Additional Locations 40 Job Category Engineering Date posted 07/01/2020

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

Summary:

  • Daily activities include leading technical complaint evaluations, educating international teams on product failures, calibration, validation activities, and manufacturing operation support from raw materials to finished device.  Maintain the Risk Management process and related documentation based on, not limited, complaint evaluation and calibration signals (OOT), and closely interact with product design and vigilance functions to address quality issues and facilitate continuous improvement of product quality and reducing product complaints. 
  • Supervise, coach and develop calibration personnel.  Establish and execute value improvement opportunities (Lean Six Sigma).   Ensure operation continuity and eliminate redundant or unnecessary calibrations.   Make recommendations on in house versus external calibration tradeoffs (business acumen), equipment calibration frequency, replacement, or new equipment substitute based on OOT, equipment age, or other data signals.
  • Conduct/Manage small projects without assistance.  This includes constructing detailed project requirements and interfacing with cross-functional team members from but not limited to calibration, engineering, post market surveillance, operations and other groups.

Essential Duties and Responsibilities:

  • Apply standard operating practices and problem-solving methodology. Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics not being met.
  • Map Risk Management Documentation for all product families based on, but not limited to, complaint and calibration signals. 
  • Be the technical bridge between Irvine Engineers, Irvine complaint evaluation team, compounding center leads and international quality personnel. 
  • Maintain and develop new Key Performance Indicators (KPI) to measure efficiency and effectiveness in, but not limited to, complaints and calibration.
  • Lead problem solving within and outside of the plant to successfully reduce CIPM and improve customer satisfaction and patient safety.
  • Lead meetings and MOH responses relating to international and domestic requests from the cross functional teams relating to products manufactured at Baxter Irvine.
  • Determine NCR applicability based on Product Risk Threshold Table (PRTT) and own NCR/SNCR/CAPA in improving product reliability and customer satisfaction. 
  • Supervise, coach and develop calibration technicians in value improvement projects, establishing wider cross training and coverage, risk and data-based calibration program for frequency or replacement. 
  • Supervise, coach and develop calibration technicians in value improvement projects to drive financial sustainability, improve cross training and coverage and improve equipment reliability leading to process continuity.
  • Evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance in the field to generate proactive and timely actions when needed.
  • Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws.
  • Other validation duties as assigned.
  • Other duties as assigned.

Qualifications:

  • Direct or indirect industry knowledge in Post Market Surveillance or complaint evaluation, Calibration, Process Validation, Risk Management, Total Quality Management (e.g. Six Sigma, Quality by Design, Statistical Process Controls).
  • Supervisory experience in calibration or related area.
  • Completely proficient in relevant products, complaint evaluations, calibration, risk management, NCR/CAPA and project management.
  • Extensive cross-functional team experience, including technical and non-technical work.
  • Ability to organize and present technical and project management. overviews without assistance.
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Proficiency in Microsoft Word, Project, Excel, Minitab, and other computer software.
  • Ability to execute routine tasks timely, accurately. Ability to prioritize multiple tasks.

Education and/or Experience:

  • Bachelor degree in Science of Mechanical or Electrical Engineering
  • 3-5 years of experience in Medical Device or in a Pharmaceutical or Chemical Process Industry is desired.
  • Be familiar with Lean Manufacturing and Six Sigma concepts

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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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Corporate Responsibility

“We believe that our mission to save and sustain lives is our ultimate statement of corporate responsibility. The global impact of our products, presence and activities will always be assessed through this lens, as we touch the lives of patients, clinicians, communities, employees and other constituencies worldwide."

Joe Almeida, Chairman and CEO

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Rewards

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    Health & Well-Being

    Employee Health and Well-Being Benefits are offered to employees and their families. In some locations, employees have the opportunity to choose the healthcare benefits that best meet their needs.

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    Continuing Education/ Professional Development

    We believe that employees grow and learn through a combination of work experiences, feedback, relationships and training.

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    Paid Time Off

    Paid Holidays schedules vary by location, but generally include both standard holidays and company-designated days.

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    Support for Parents

    We support working parents with programs that vary by location, including parental leave, and adoption assistance.

Career Growth

  • Engineer Engineer
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    People Management People Management
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Culture

  • Expanding our reach to help patients and providers
  • Making meaningful difference in our communities
  • Providing meaningful career experiences driven by our passion to save and sustain lives

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