Design Quality Director — Medical Devices

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

Benefits offered by this job

Benefits package

Flexible workplace

Onsite requirement

Job summary

Baxter is seeking a Director of Design Quality to lead the design, development, and lifecycle management of Infusion Systems products, including pumps, sets, and software.

You will guide a team of design quality professionals, set strategy, and ensure compliance with global regulatory standards while driving continuous improvement and collaboration across functions. The role emphasizes hands-on execution and industry leadership.

Qualifications

• Bachelor's degree in engineering or related field required.
• 10+ years in quality, engineering, or product development with 7+ years in management.
• Deep knowledge of medical device, biologics, and regulatory standards.

Responsibilities

• Lead a team of Design Quality professionals responsible for product development and lifecycle management.
• Develop and implement design quality strategies aligned with goals, standards, and regulatory requirements.
• Establish and monitor design quality KPIs, driving continuous improvement initiatives.
• Serve as a subject matter expert on design quality and support cross-functional teams.
• Partner with Quality System stewards to maintain and improve the Quality System.
• Stay abreast of industry trends and regulatory changes and apply insights.
• Represent Baxter in industry forums and standards committees.

Skills

Quality leadership

Regulatory knowledge

Quality engineering

Risk management

Decision making

Conflict resolution

Cross-functional

Product development

Medical device regs

Education

Bachelor's in engineering

Advanced degree preferred

Job description

Baxter is seeking a Director of Design Quality to lead the design, development, and lifecycle management of Infusion Systems products, including pumps, sets, and software.

You will guide a team of design quality professionals, set strategy, and ensure compliance with global regulatory standards while driving continuous improvement and collaboration across functions. The role emphasizes hands-on execution and industry leadership.