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

The Principal Engineer is responsible for supporting the quality and regulatory related matters associated with the medical bed devices. This position 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. The Principal Engineer will need to maintain a teamwork approach to all tasks and nurture professional relationships with other departments and outside agencies.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

• Serve as a primary point of contact for quality related matters associated with support for medical bed devices.
• Drive quality system improvements and ensure compliance to regulatory and procedural requirements.
• Responsible for leading quality initiatives with operations to improve manufacturing processes and product quality.
• 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.
• Support operations in trouble-shooting non-conformities to confirm part defects.
• Participate in external and internal regulatory compliance inspections.
• 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.
• Lead the Health Hazard Evaluation activities for the assigned areas.
• Ensure appropriate controls (key metrics) are defined, implemented, and satisfactorily completed for all appropriate operations.
• 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.
• 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).
• Investigate product quality problems, determine root cause, gather, and analyze data and implement corrective action to reduce or eliminate cause.
• Work closely with Operations to Identify and resolve production and quality system deficiencies.
• Participate in the improvement of the manufacturing process for existing products. Review and approve work instructions, inspection documents, Bills of Material, and drawings.
  

What you'll bring

• Bachelor's Degree in Engineering or related field.
• 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.
• 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.
  

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 $96,000 - $132,000 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. This position may also be eligible for discretionary bonuses. 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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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.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.