Baxter
Healthcare
SrEngineer,Quality
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr Engineer, Quality at Baxter. Skills: Quality Engineering, Process validation, Risk management. Provide engineering support. Ensure compliance with GMP/QSRs”
Industry & Context.
Root cause analysis
Authorized to work in US
What They're Looking For.
Must Have
Minimum 3 years experience in regulated manufacturing, BS degree required
Nice to Have
Experience leading cross-functional teams, Familiarity with MINITAB, Engineering Technology/Microbiology/Chemistry degree depending on experience
What You'll Do.
Provide engineering support
Ensure compliance with GMP/QSRs
Lead project-based individual contributors
Mentor Quality Engineers
Implement new processes
Develop new computer systems
Improve existing methods
Define system requirements
Define system design specifications
Support manufacturing plant
Implement process improvements
Conduct process analysis
Conduct financial analysis
Implement improvements
Manage small projects
Manage project change management
Manage project implementation
Manage project validation
Lead cross-functional teams
Lead validation programs
Lead verification programs
Perform statistical analysis
Evaluate sampling plans
Evaluate testing plans
Evaluate qualification plans
Accountable for testing
Conduct in-process risk assessment
Conduct situation appraisal
Compose final reports
Compose general information reports
Lead validation efforts
Coordinate validation efforts
Assist in evaluation of customer complaints
Assist in evaluation of risk management
Assist in evaluation of technical summaries
Assist in evaluation of supplier product changes
Assist in evaluation of supplier process changes
Assure compliance of manufacturing operations
Assure compliance of quality control operations
Implement engineering knowledge
Implement statistical tools
Implement six sigma tools
Identify improvement opportunities
Support CAPA investigation
Review CAPA investigation
Approve CAPA investigation
Own CAPA investigation execution
Initiate action to prevent nonconformities
Establish process controls
Establish verification monitoring
Drive improvements into production process
Maintain safe work environment
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Technical writing
Process & Methodology
Cost management, Change management, Implementation, Validation
Full Job Description
**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. **What You 'll Be Doing** * Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods. Requirements for new/improved machines/processes/computer systems, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions. * 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/drive
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