Director, Design Quality - Infusion Systems
About The Position
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter 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. Your Team at Baxter 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; 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
