Director, Design Quality - Infusion Systems

Baxter•Round Lake, IL

9d•Hybrid

About The Position

This is where your creativity addresses challenges 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. You are creative, detailed, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it will touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

Requirements

Bachelor's in engineering, science, or related field required
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

Nice To Haves

Advanced degree preferred

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.

Benefits

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits