Quality Engineer I

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. 

Your role at Baxter

This is where your expertise helps people

You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your role at Baxter

The Quality Engineer I provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. The job contributes engineering/technical expertise through the Quality Management function to the manufacturing facility. The Quality Engineer’s duties span the environment of both the project engineer and the quality engineer. However, it does involve the procurement of funding for capital investment, ROI analysis, quality trend analysis, research of the optimum equipment for the task, and implementation of that equipment, to include the validation phase.

The Quality Engineer is accountable for the validation process. The job requires basic engineering skills, statistical/six sigma skills, numerical analysis techniques and implementation skills for process improvement. Knowledge of all validation phases is a must, from the conception of the project to the final signature.

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 working 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 with respect to 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

• BS 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 $72,000 - $99,000 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. This position may also be eligible for discretionary bonuses. 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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

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