Senior Quality Engineer

Baxter International Inc. • Saint Paul, MN

1d • $88,000 - $121,000

About The Position

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. Your Role: 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.

Requirements

• BS in Engineering or related field of science.
• 3 - 5 years of experience in Manufacturing Quality, Design Assurance or Quality Systems.
• 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.

Nice To Haves

• Sterilization and Process Validation experience.
• ASQ Certification in Quality Engineering.
• Previous Quality System auditing experience.

Responsibilities

• 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.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees