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. Your Role at Baxter This is where your expertise helps people! You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions. Your Team We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge. When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development. As a Senior Product Quality Engineer, you will have the opportunity to lead by example and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish. What You'll Be Doing Investigate product quality problems, determine root cause, gather, and analyze data and implement corrective action to reduce or eliminate cause. Drive quality system improvements and ensure compliance to regulatory and procedural requirements. Participate in the improvement of the manufacturing process for existing products. Review and approve work instructions, inspection documents, Bills of Material, and drawings.

Serve as a primary point of contact for quality related matters. Responsible for leading quality initiatives with operations to improve manufacturing processes and product quality.

Interface with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.

Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection.

Support operations in trouble-shooting non-conformities to confirm part defects.

Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ). Participate in external and internal regulatory compliance inspections and assist in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.

Lead the Health Hazard Evaluation activities for the assigned areas.

Ensure appropriate controls are defined, implemented, and satisfactorily completed for all appropriate operations. Collect, analyze, and track key data across the Batesville manufacturing site related to entity quality and to monitor and to monitor key performance indicators by working with key partners across the corporation.

Ensure accurate and timely processing of all Quality Records along with the company’s regulatory compliance profile per 21CFR820 regulations.

Provide training to ensure proper implementation and use of quality tools and procedures as required.

Enable rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.

Review/approve nonconforming materials and associated documentation.

Review/approve product and process change control documentation and specifications.

Use quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).

Work closely with Operations to Identify and resolve production and quality system deficiencies

What You'll Bring Bachelor's Degree in Engineering required.

1-3 years of experience in Design, Operations or Quality.

Working experience with ISO 13485, MDD, MDSAP, EUMDR Regulations preferred.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. #LI-LS1 Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Learning / Doing (1)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0)) US Benefits at Baxter (except for Puerto Rico)