Director, Design Quality — Lead Medical Device Quality & Strategy

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

Benefits offered by this job

Health and dental benefits

401(k) with company match

Flexible paid time off 20–35 days

Job summary

Baxter International Inc. seeks a Director of Design Quality to lead the Design Quality team and ensure the highest quality design and development of Infusion Systems products, including pumps, sets, and software.

This role requires strategic leadership, cross‑functional collaboration, and a deep understanding of regulatory standards. You will drive design quality by establishing KPIs, partnering with Quality System stewards, and staying ahead of industry trends.

Qualifications

• Bachelor's in engineering, science, or related field required.
• 10+ years in quality, engineering, or related product development; 7+ years managerial.
• Deep understanding of medical device, biologics, and combination product development cycle.
• Strong knowledge of regulatory requirements and industry 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 and regulatory requirements.
• Establish and monitor design quality KPIs; drive continuous improvement.
• Serve as SME on design quality; support cross‑functional teams and external partners.
• Collaborate to develop, maintain, and improve Quality System elements.
• Stay current with industry trends and regulatory changes; integrate insights.
• Represent Baxter in industry forums, conferences, and standards committees.

Skills

Quality leadership

Quality management

Risk management

Quality engineering

Decision making

Conflict resolution

Cross-functional collaboration

Education

Bachelor's in engineering/science

Advanced degree preferred

Job description

Baxter International Inc. seeks a Director of Design Quality to lead the Design Quality team and ensure the highest quality design and development of Infusion Systems products, including pumps, sets, and software.

This role requires strategic leadership, cross‑functional collaboration, and a deep understanding of regulatory standards. You will drive design quality by establishing KPIs, partnering with Quality System stewards, and staying ahead of industry trends.