This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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: The Senior Quality Engineer provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. This role may lead project-based individual contributors / contractors or mentor newer Quality Engineers as needed.
Job Responsibility
Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
Supports the manufacturing plant through implementation of process improvements
Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
Perform statistical analysis to support Quality and Production
Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
Composes protocols, final reports, studies, experiments and general information reports for use by management
Routes documents in the Document Management System
Leads/coordinates validation efforts of new equipment and changes to existing equipment
Assist in evaluation of customer complaints, risk management and technical summaries
Assist in evaluation of supplier product/process changes
Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations
Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement
Supports, review and approve, and may own execution of CAPA investigation with use of DMAIC process and technical writing skills
Requirements
Strong technical writing, investigation and communication skills required
Experience leading cross-functional teams preferred
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.) Familiarity with MINITAB preferred
Minimum 3 years of experience in regulated manufacturing environment
BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
Applicants must be authorized to work for any employer in the U.S.
Nice to have
Experience leading cross-functional teams preferred
Familiarity with MINITAB preferred
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 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