Baxter

Healthcare

SrEngineer,Quality

$96–132k Hayward, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Sr Engineer, Quality at Baxter. Skills: Quality Engineering, Process validation, Risk management. Provide engineering support. Ensure compliance with GMP/QSRs”

Industry & Context.

Healthcare
Problems you'll solve

Root cause analysis

Eligibility Requirements

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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