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Senior Quality Engineer

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BD

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Location:
United States , Sparks

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

92700.00 - 152900.00 USD / Year
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Job Description:

Senior Quality Engineer has responsibility for working independently, with cross functional teams or leading projects with minimal oversight. They are responsible for effectively interpreting the applicable Quality Systems policies, regulations and plant level procedures. Ensures that plant practices and product process and documentation are compliant. Assesses Critical To Quality (CTQ) parameters and makes risk assessments as part of the decision making processes to support product disposition.

Job Responsibility:

  • Initiates and/or supports CAPAs and may lead the investigation/corrective action process
  • Responsible for the various aspects of ID/AST plant sustaining, validation, & NPD Quality Engineering, including routine Quality Engineering responsibilities for assigned ID/AST products and quality system focus
  • Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to the product line
  • Uses tools for risk analysis/management, 8D, validation, and project management, sampling plans, Six Sigma, control plans, design control and trending
  • Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes, and verifies effectiveness of changes
  • Develops and maintains efficient methods for regularly reporting status to management the product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements

Requirements:

  • Bachelor's Degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field with minimum of 5 years’ experience within the quality function or Master’s Degree with minimum of 3 years' experience in quality
  • Experience handling multiple projects simultaneously in a fast-paced environment
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint) required
  • Pharma/Medical device industry experience preferred
  • Experience with Minitab or other statistical analysis platforms preferred

Additional Information:

Job Posted:
January 22, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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