Director of Design Quality - Medical Devices & Software

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

Benefits offered by this job

Health insurance

401(k) plan

Flexible workplace policy

Onsite wellness program

Job summary

Baxter International Inc. 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 guide a team of quality professionals, drive strategic design quality initiatives, ensure regulatory compliance, and partner with cross-functional teams to deliver safe, high-quality medical devices. This role offers a competitive base salary, comprehensive benefits, and a flexible workplace policy with onsite

Qualifications

• Bachelor's degree in engineering, science, or related field.
• 10+ years of experience in quality, engineering, or related product development function.
• 7+ years of managerial experience.
• Detailed understanding of medical device, biologics, and combination product development cycle and regulatory requirements.
• Breadth and depth in quality decision-making, risk management, and quality engineering.

Responsibilities

• Lead a team of Design Quality professionals responsible for product development lifecycle and post-market monitoring.
• Develop and implement comprehensive design quality strategies aligned with goals, industry standards, and regulatory requirements.
• Establish and maintain design quality KPIs with regular reviews to drive improvements.
• Serve as a subject matter expert on design quality and support 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, new technologies, and regulatory changes and apply insights.
• Represent the company in industry forums, conferences, and standards committees.

Skills

Quality leadership

Regulatory knowledge

Design quality

Medical device experience

Risk management

Education

Bachelor's in engineering or related field

Advanced degree preferred

Job description

Baxter International Inc. 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 guide a team of quality professionals, drive strategic design quality initiatives, ensure regulatory compliance, and partner with cross-functional teams to deliver safe, high-quality medical devices. This role offers a competitive base salary, comprehensive benefits, and a flexible workplace policy with onsite