Baxter International

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Job Summary:

We are seeking a highly skilled and experienced Director of Design Quality to lead our team in ensuring the highest quality design and development of our Infusion Systems products including infusion pumps, sets and health software.

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 manage 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 identify areas for improvement and drive continuous improvement initiatives.
• Foster a culture of quality and continuous improvement, promoting best practices and driving process improvements to enhance product safety, performance, and user experience.
• Serve as a subject matter expert on design quality matters, providing guidance 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, emerging technologies, and regulatory changes, and incorporate relevant insights into design quality strategies and initiatives.
• Represent the company in industry forums, conferences, and standards committees, sharing knowledge and contributing to the advancement of the medical device industry.

Qualifications:

• Bachelor's in engineering; advanced degree preferred.
• Minimum of 10 years of combined experience in quality, engineering or a related product development function with 7+ years of managerial experience.
• Thorough understanding of the medical device product development cycle and expert knowledge of worldwide regulatory requirements and industry standards. Considered a Subject Matter Expert and key contributor to initiatives and advancement of the Quality organization
• Software quality experience preferred. Versed in AI and Med/Tech Software, current and future state.
• Must have strong leadership skills, take positions on Quality issues, and be capable of clearly and logically justifying such positions, both internally and externally.
• Significant breadth and depth in quality decision making, risk management, and quality engineering.
• Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills required to interact with and have ability to influence decisions.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.