Sr Engineer, Quality

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

The Senior Quality Engineer 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.  This role may lead project-based individual contributors / contractors or mentor newer Quality Engineers as needed. The job contributes to engineering and technical expertise through the Quality function to the manufacturing facility.

Your team

Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day.

Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce.

What You'll Be Doing

• Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods. Requirements for new/improved machines/processes/computer systems, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with local 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, MIP measurements and implements/drives improvements. 

• Manage small projects (both new and improvement) to include cost, change management, implementation, and validation. Leads cross-functional teams.

• Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration.

• Perform statistical analysis to support Quality and Production.

• Evaluates sampling/ testing/ qualification 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.  Routes documents in the Document Management System.

• Leads/coordinates validation efforts of new equipment and changes to existing equipment.

• 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 13485-2003, and other applicable standards and regulations.

What You'll Bring:

• Strong technical writing, investigation and communication skills required.

• Experience leading cross-functional teams preferred

• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, POMs, Maximo etc.)

• Minimum 3 years of experience in regulated manufacturing environment

• BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience.

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 $88,000 - $121,000 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.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.