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Principal Engineer, Quality

Baxter International Inc.
Batesville, United Statesfull_timeVerifiedPosted 21 Jan 2025
💰 $143,000/yr($104,000/yr$143,000/yr)

About the role

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role

This is where your expertise helps people!

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.

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.

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.

What You'll Be Doing

  • 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).

What You'll Bring

  • 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 successf

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Company

Baxter International Inc.

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