Senior Engineer

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. 

Summary

(Main purpose of the job)

Provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations, Qualifications and Validations. Identify quality issues, participate in quality improvement projects and quality activities that impact manufacturing. Other related activities include: maintenance of on-going stability validations, non-conforming material investigations, maintenance of risk management documentation, and corrective and preventive actions when required.

Essential Duties and Responsibilities

(List of primary responsibilities of this role that account for 5% or more of the work.  Incumbent may perform other duties as assigned.)

• Responsible for preparation of written Engineering Investigation, Qualification and Validation plans, statistical analysis of data and preparation of reports to support manufacturing improvements, on-going validations, and new product development efforts. 

• Provide quality engineering support for manufacturing lines, including floor support.

• Investigate and disposition nonconforming material reports (NCR events).

• Initiate, investigate, and implement corrective and preventive actions as assigned.

• Provide quality engineering support for material nonconformances including supplier corrective actions.

• Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols.

• Responsible for coordination of validation activities performed to ensure adherence to specifications and expectations.

• Initiate documentation changes and/or change control for products and processes as required to reflect validation/qualification activities and results.

• Perform internal quality system and supplier audits, as assigned.

• Complaint investigations assigned by Product Surveillance or Supervisor.

• Participate in, or lead, Kaizen or other Lean 6-sigma problem solving projects.

• Other duties as assigned.

Qualifications

(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)

• Excellent oral and written communication skills. 

• Strong problem solving, technical writing and organizational skills. 

• Self-motivated worker, persistent, curious

• Other duties as assigned.

• Working knowledge of FDA GMP and ISO 13485 requirements.

• Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma. 

• Working knowledge of MS Word, Excel, and Project applications.

• Display a solid technical understanding of engineering principles and procedures.

• Preferred; Sterilization and Process Validation experience.

• Preferred; ASQ Certification in Quality Engineering.

• Preferred; Previous Quality System auditing experience.

Education and/or Experience

• BS in Engineering or related field of science.

• 3 - 5 years of experience in Manufacturing Quality, Design Assurance or Qual