Director, Design Quality - Infusion Systems
Baxter International Inc.
Summary
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.
Job description
Your Role at Baxter
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.
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.
Requirements
- 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.
Benefits
- Medical coverage
- Dental coverage
- Life insurance
- Accident insurance
- Short-term disability
- Long-term disability
- Business travel accident insurance
- Employee Stock Purchase Plan
- 401(k) Retirement Savings Plan
- Flexible Spending Accounts
- Educational assistance
- Paid holidays
- Paid time off
- Family and medical leave
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.