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Sr Quality Engineer

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Irvine

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

96000.00 - 132000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • Provide Quality Engineering support to one or more product lines at the Irvine facility
  • support manufacturing operation from raw materials to finished device
  • maintain Risk Management process and related documentation
  • closely interact with product design and vigilance functions to address quality issues and facilitate continuous improvement of product quality
  • support sustaining of production processes in a state of control and compliance through planning, execution and implementation of process validation and controls
  • author and review validation processes and procedures
  • make recommendations for changes and/or improvements
  • evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance
  • assure product compliance to specifications through implementation of inspection criteria and procedures
  • develop and analyze statistical data and product specifications to ensure product quality
  • apply standard operating practices and problem-solving methodology
  • perform root cause investigation analysis and prepare reports
  • organize, review and perform computer system validation or other software validation related evaluations
  • support data integrity initiatives
  • develop and maintain Risk Management Documentation including software risk
  • perform validation activities as assigned
  • partner with Project and Manufacturing Engineering
  • evaluate and/or perform computer system validation for applicable software or GxP computerized systems
  • analyze and perform assessments for software change controls
  • provide coaching and mentoring regarding CSV, SDLC, data integrity and cyber security standards
  • other duties as assigned

Requirements:

  • BA or BS in Engineering with 3 to 5 years related experience or demonstrated performance within Quality Engineering
  • Master’s degree can be used in lieu of 2 years of related experience
  • Lean or Six Sigma Green Belt or higher preferred
  • demonstrated experience on process validation and risk management for medical device
  • engineering depth and ability to understand product and process operating principles
  • strong verbal and written communication skills
  • documentation practices (cGDPs)
  • self-motivated
  • strong interpersonal skills
  • ability to update procedures and modify processes to simplify complexity and improve efficiencies

Nice to have:

  • Lean or Six Sigma Green Belt or higher
  • Master’s degree in Engineering or Business Administration
What we offer:
  • Support for Parents
  • Continuing Education/Professional Development
  • Employee Health & 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
  • 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
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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