Baxter International Inc.
Sr Manager, Design Quality,
Baxter International Inc., Round Lake, Illinois, United States, 60073
Sr. Manager, Design Quality
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.
In this role, you 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.
Compensation & Benefits 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.
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.
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 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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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.
In this role, you 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.
Compensation & Benefits 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.
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.
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 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.
#J-18808-Ljbffr