Senior Engineer, Quality

Regulatory Jobs; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Job summary

Baxter is seeking a Senior Engineer, Quality to join our Infusion Therapies and Platforms team in Round Lake, IL. You will support product life cycle activities, quality processes, and design quality initiatives across a broad range of Baxter therapies.

The role emphasizes cross-functional collaboration, support for R&D and investigations, and leading risk assessments and CAPA boards to improve product quality. Strong ISO knowledge and regulatory experience are essential.

Qualifications

• BS in Engineering or Science with 3–5 years of related experience.
• Master’s degree can substitute for 2 years of experience.
• Experience with quality systems/ISO requirements.

Responsibilities

• Lead post market risk assessments to evaluate actions.
• Lead product performance investigations and trend analysis.
• Participate in cross-functional complaint, change control and CAPA boards.
• Support audits and inspections readiness.
• Provide quality support to R&D, labs and instrument qualification.
• Contribute to design quality in new product development projects and manage complex issues.
• Define scope of quality deliverables for NPD and SPO.

Skills

Interdisciplinary understanding

Stakeholder influence

Cross-functional teamwork

Business-aware problem solving

Problem solving under ambiguity

ISO quality standards

Regulatory compliance

Education

BS in Engineering or Science

Master’s degree substitute 2 years experience

Job description

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

Baxter seeks a Senior Engineer, Quality to join our Infusion Therapies and Platforms business in Round Lake, IL. Senior Engineer, Quality is an exciting role in supporting solutions and container design activities within our Design Quality team. This position involves further improving our product quality by actively supporting management of product life cycle activities for a wide array of Baxter’s Therapeutic products and associated manufacturing / quality processes.

This role is based out of the Round Lake, IL location.

What you'll be doing

• Leads Post Market Risk Assessments of product issues to assess the need for Action
• Leads product performance investigations via failure analysis in individual complaints or through the evaluation of product-related trends (e.g., complaint, SCAR)
• Leads or participates in cross functional Complaint, Change Control and CAPA Review Boards
• Supports cross functional teams in the readiness for any potential internal and/or external audits and inspections
• Provides Quality support to R&D and laboratory studies, investigations, and instrument qualification activities
• Function as Quality Core Team member supporting new and improved product design and implementation projects (including large programs) and manage a variety of complex issues in associated projects
• Responsible for defining scope of quality deliverables and support for NPD and SPO development activities

What you'll bring

• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
• Ability to engage management and other functions to influence decisions on courses of action with minimal assistance using both written and verbal methods.
• Effectively operate in and facilitate cross-functional teams with minimal guidance.
• Must be able to provide solutions that reflect understanding business objectives, cost implications, and engineering challenges.
• Capable of problem solving and dealing with ambiguous situations.
• Experience with quality systems/ISO requirements.
• Working knowledge of environmental, safety, and regulatory compliance in a regulated manufacturing environment

Education and/or Experience

• Minimum of a BS in Engineering or Science having a minimum of 3 to 5 years related experience or demonstrated performance within Quality or Engineering.
• A Master’s degree can be used in lieu of 2 years of related 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 $96,000 - $132,000 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 upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements.At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

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,

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.

Know Your Rights: Workplace Discrimination is Illegal

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.