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Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. 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.
Job Responsibility:
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
Maintenance of on-going stability validations, non-conforming material investigations, maintenance of risk management documentation, and corrective and preventive actions when required
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
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
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 have:
Sterilization and Process Validation experience
ASQ Certification in Quality Engineering
Previous Quality System auditing experience
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service