Director of Design Quality – Infusion Systems (Medical Devices)

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

Benefits offered by this job

Medical and dental coverage

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Savings Plan with 회사

Flexible Spending Accounts

Paid time off 20–35 days

Parental leave

Employee discounts

Job summary

Baxter is seeking a Director of Design Quality to oversee the design and development of Infusion Systems products, including infusion pumps, sets, and health software. You will lead a team responsible for quality across the product lifecycle, from development through post-market monitoring.

You will drive design quality strategies, maintain KPIs, stay current with regulatory changes, and represent Baxter in industry forums.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality management

Team leadership

Regulatory knowledge

Risk management

Quality engineering

Conflict resolution

Education

Bachelor’s in engineering/science

Advanced degree preferred

Job description

Baxter is seeking a Director of Design Quality to oversee the design and development of Infusion Systems products, including infusion pumps, sets, and health software. You will lead a team responsible for quality across the product lifecycle, from development through post-market monitoring.

You will drive design quality strategies, maintain KPIs, stay current with regulatory changes, and represent Baxter in industry forums.