Quality Engineer I
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Your Role
This is where your creativity addresses challenges
The Quality Engineer displays technical understanding and ability to analyze complaints and actively support team efforts to achieve goals. Under the direction of the manager you will be responsible for conducting complaint analysis, supporting product design changes, and gathering data to support investigation of non-conformances.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
What you'll be doing
- Leads or assists in developing and implementing new machines/processes and in improvements to existing methods. Requirements for new/improved machines/processes, including system specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with Mountain Home Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
- Supports the manufacturing plant through implementation of process improvements.
- Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives change.
- Manage small projects (both new and improvement) to include cost, implementation, and validation.
- Provides statistical assistance to Quality and Production.
- Evaluates sampling plans for current quality levels and test methods.
- Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
- Composes protocols, final reports, studies, experiments, and general information reports for use by management.
- Leads/coordinates validation efforts of new equipment and changes to existing equipment.
- Assist in evaluation of customer complaints, risk management and technical summaries.
- Assist in evaluation of supplier product/process changes.
- Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO 13485-2003, Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC 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.
- Support department execution of CAPA investigations with use of DMAIC process and technical writing skills.
- Excellent Technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities.
- Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
- Identifying and recording any 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.
What you'll bring
- Bachelor of Science degree in Engineering required.
- Strong technical writing and investigation skills required.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $68,000 - $102,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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 - Poster Supplement
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
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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.