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Sr Manager, Design Quality

Req # JR - 188751 Location Round Lake, Illinois, United States Job Category Quality Date posted 10/21/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Sr Manager, Design Quality

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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. 

You role at Baxter

The Sr. Manager, Design Quality will individually contribute and manage through team members the activities within the Round Lake Infusion Pump New Product Development (NPD) and post market support Design Quality team. This role is responsible for results in terms of compliance and conformance to regulations and Baxter Quality policies.

What you will be doing

Team leadership & development

  • Lead, coach, mentor, and develop a team of quality / design quality engineers and specialists
  • Allocate resources, set goals, conduct performance reviews, build bench strength

Design Quality & Lifecycle Oversight

  • Provide oversight and input across all stages of product development: design inputs, design reviews, verification/validation, risk management, design transfer
  • Ensure seamless design to manufacture transitions, including plans, protocols, acceptance criteria, and training

Post-Market Quality & Field Support

  • Lead root cause analysis, CAPA, complaint handling, trend analysis, corrective & preventive actions
  • Partner with field service / support teams to triage and resolve product anomalies
  • Monitor post-market metrics and lead improvement initiatives

Regulatory Compliance & Inspection Readiness

  • Ensure conformance to FDA QSR / 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and other global standards
  • Serve as the quality SME during regulatory audits / inspections; lead responses and corrective plans
  • Support internal audits, supplier audits, and third-party assessments

Cross-Functional Collaboration & Influence

  • Act as the primary quality liaison to R&D, systems, manufacturing, supplier quality, regulatory, and service
  • Influence roadmaps, design tradeoffs, and project schedules to embed quality early

What do you bring

  • BS in science or engineering.

  • 8+ years of experience in Quality, Manufacturing, R&D Engineering or related field.

  • 3+ years in a supervisory or leadership role managing quality engineers

  • Experience with electromechanical devices strongly preferred

  • Thorough knowledge of applicable procedures, specifications, regulations and standards related to Medical Device product development and post market support.

  • Proven experience interacting with regulators and leading inspections or audits

  • Strong analytical, problem-solving, and decision-making capability

  • Excellent verbal and written communication, influencing, negotiation, and stakeholder engagement

  • Project management skills: ability to drive multiple concurrent projects with cross-functional teams

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $136,000 to $187,000, plus an annual incentive bonus, commission target, and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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.

#LI-BAXGEN

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.

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.

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Address

Explore this location 25212 W Illinois Route 120 RL/Plastics
Round Lake, IL 60073
United States of America Explore This Location

Hear from Our Employees

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 Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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