Quality Engineer

Overview

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

• Lead product and process improvement & NCR/CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure.
• Apply problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner.
• Perform root cause investigation analysis and data trending for NCR/CAPA.
• Manage project documentation in “Track Wise” system in compliance with Baxter practices and procedures.
• Perform monitoring of metrics in support of site and company goals and objectives.
• Support other teams in Investigation of customer complaints or internal events.

Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day.

Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each day. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce.

• Apply sound engineering practices and problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner.
• Act independently with minimal supervision to investigate and analyze process or product issues and design improvement suggestions based on recent technical knowledge.
• Perform root cause investigation analysis and document within the quality system as appropriate (NCR/CAPA).
• Design and perform routine testing, project experiments, analysis of data and reports results.
• Perform engineering studies on new equipment to determine proper settings, control points, etc. including data gathering during start up and test batches.
• Work with manufacturing and other functional groups on manufacturing regulatory compliance issues.
• Write, execute, and develop report for validation activities, including qualification protocols.
• Perform work assignments within production department that include training, technical support and/or process trouble shooting support.
• Lead product and process improvement & NCR/CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure.
• Serve as CAPA Site Representative and Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).

• Understanding of engineering principles in various engineering disciplines related to medical device manufacturing.
• Bachelor’s degree in engineering. 1 - 3 years of experience.
• Demonstrated ability to effectively run projects and direct the activities associated with those systems in regulated environment.
• Strong command of problem-solving techniques and ability to coach others in their application.
• Must be able to write clearly and informatively, present numerical data effectively, able to read and interpret written information.
• Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
• Ability to work collaboratively in a team-oriented environment.
• Working knowledge of FDA quality system regulations.
• Working knowledge of Quality Management System.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to…