Director, Design Quality - Infusion Systems

Baxter; Round Lake (IL); On-site; USD 176,000 - 242,000; Full time

Benefits offered by this job

Flexible workplace policy

Onsite collaboration

Job summary

Baxter in the United States is seeking a Director of Design Quality to lead the design quality of Infusion Systems products, including pumps, sets, and software. You will build and mentor a team, define quality strategies, ensure regulatory alignment, and drive continuous improvement across development and post-market activities.

This leadership role requires deep expertise in medical device quality, risk management, and cross-functional collaboration.

Qualifications

• Bachelor's in engineering, science, or related field.
• 10+ years of experience in quality, engineering, or a related product development function.
• 7+ years of managerial experience.
• Knowledge of medical device regulatory requirements and industry standards.
• Breadth in quality decision-making, risk management, and quality engineering.

Responsibilities

• Lead a team of Design Quality professionals responsible for product development, lifecycle management activities, and post-market monitoring.
• Develop and implement comprehensive design quality strategies aligned with company goals, industry standards, and regulatory requirements.
• Establish and maintain design quality KPIs, conducting regular reviews to drive continuous improvement.
• Serve as a subject matter expert on design quality, providing support to cross-functional teams and external partners.
• Partner with Quality System element stewards to develop, maintain, and improve the Quality System.
• Stay abreast of industry trends and regulatory changes and incorporate insights into strategies.
• Represent the company in industry forums and standards committees.

Skills

Leadership

Quality engineering

Risk management

Regulatory compliance

Conflict resolution

Education

Bachelor's degree in engineering or related field

Advanced degree preferred

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

This is where your creativity addresses challenges

As Director of Design Quality, you will ensure the highest quality design and development of Infusion Systems products including infusion pumps, sets, and health software.

You are creative, detailed, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it will touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What you'll be doing

• Lead a team of Design Quality professionals who are responsible for product development, lifecycle management activities, and post-market monitoring.
• Develop and implement comprehensive design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements. Set and lead priorities within the team based on these strategies and business needs.
• Establish and maintain design quality and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives.
• Serve as a subject matter expert on design quality matters, providing expertise and support to cross-functional teams and external partners.
• Partner with Quality System element stewards to develop, maintain, and improve the Quality System in relevant areas.
• Stay abreast of industry trends, new technologies, and regulatory changes, and incorporate relevant insights into strategies and initiatives.
• Represent the company in industry forums, conferences, and standards committees, sharing knowledge to the advancement of the medical device industry.

What you'll bring

• Bachelor's in engineering, science, or related field required; Advanced degree preferred.
• 10+ years of experience in quality, engineering, or a related product development function, 7+ years of managerial experience.
• Detailed understanding of the medical device, biologics, and combination product development cycle, knowledge of worldwide regulatory requirements and industry standards.
• Significant breadth and depth in quality decision-making, risk management, and quality engineering.
• Conflict resolution skills including persuasive management techniques required.

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 $176,000 - $242,000 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, commission, and/or long-term incentive.

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.