Senior Product Quality Engineer

Overview Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. • Support for Parents • Continuing Education/ Professional Development • Employee Health & Well-Being Benefits • Paid Time Off • 2 Days a Year to Volunteer Success Profile What makes a successful Engineer at Baxter?

Take a look at some of the top traits we’re looking for and see if you’re a fit. • Problem Solver • Analytical Thinker • Data Driven • Solution Focused & Results Oriented • Collaborative • Innovative 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 We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment.

Together, we build and maintain a positive work environment. When you join us, you will work with 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. What Youll 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 data across the Batesville manufacturing site related to entity quality and monitor key performance indicators by working with key partners. • 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 & 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 Ops to identify and resolve production and quality system deficiencies. What Youll Bring • Bachelors Degree in Engineering or related field • 2 to 5 years of related work experience • Working experience with ISO 13485, MDD, MDSAP, EUMDR Regulations preferred • Ability to work and perform in a team environment and effective interpersonal skills • Demonstrated high attention to detail • Excellent analytical decision making and problem-solving skills • Proven ability to resolve issues and participate in process improvement activities • Track record of successful business and customer orientation • Excellent written and verbal skills • Ability to define problems, collect data, establish facts and draw conclusions • Ability to effectively present information in one-on-one and small group situations We understand compensation is an important factor as you consider the next step in your career.

At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change.

Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law