Principal Engineer, Quality

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.

The Principal Engineer will be supporting the quality and regulatory related matters associated with the medical bed devices. In this role you will also be responsible overseeing and/or assisting with a variety of Quality Engineering functions and ensuring compliance with QSR regulations and related policies and procedures. In addition, this position will work to provide the necessary data to make effective quality and business decisions, and implement sound, data-driven solutions that emphasize quality system compliance. You will need to maintain a partnership approach to all tasks and cultivate professional relationships with other departments and outside agencies.

Your talent is needed across a wide variety of industries. As a Principal Engineer, you have a wide array of career choices, but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission.

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.

Our team is dedicated to quality. 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.

• Serve as a primary point of contact for quality related matters associated with support for medical bed devices.

• Collaborate 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.

• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ).

• Participate in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.

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

• Collect, analyze, and track key data across the Batesville manufacturing site related to entity quality and monitor key performance indicators by working with key partners across the corporation.

• 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).

• Bachelor's Degree in Engineering required.

• 5+ years of experience in Quality, Manufacturing, or related field.

• Supervisor/Manager experience preferred.

• Proficient with Quality System Regulations, MDR, and ISO Quality System Standards.

• Strong understanding of ISO 13485 preferably.

• 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.

• Ability to define problems, collect data, establish facts and draw conclusions.

• Ability to effectively present information in one-on-one and small group situations.

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.

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 base salary for this position is $104,000 - $143,000 annually. 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. 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.

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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.

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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.

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