Job Description

This is where you save and sustain livesAt 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.Your role:

• Overall responsibility for maintaining site compliance with the requirements of the Baxter Quality Management System (QMS).
• Assure excellence in site implementation of the product development process. Responsible for on-site training on product development, change control, nonconformance / CAPA processes and design best practices.
• Responsible for building and developing a quality team that are experts in design assurance practices and actively partner with R&D teams to assure a high quality product.
• Collaborate with teams to provide strategy and guidance for meeting Baxter requirements and External Quality Standards as appropriate.
• Organize and implement site support of Corporate audits and Notified Body regulatory inspections.

What you will bring:

• Demonstrated knowledge in the areas of medical device design controls, change control, CAPA, and risk management.
• Strong interpersonal/communication/influencing/negotiation skills required. Demonstrated leadership and communication skills accomplishing success with large teams
• Keen eye for business and international experience.
• Proven track record of successful regulatory inspection involvement required.
• Strong critical thinking and problem-solving skills using DMAIC tools, Six Sigma Engineering, ASQ or other certifications desirable.
• Bachelors degree (engineering or science related field)
• 18+ years of experience in Quality and/or Engineering in the Medical Device field with 5-7 years of management experience.
• Experience in the design and development of software and/or electromechanical devices is required.
• Be an example of the Baxter mission: collaboration, speed, courage, and simplicity.

Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .

Baxter