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BioPharma Consulting JAD Group

Senior Quality Engineer - Metrology and Calibration

Houston, Texas, United StatesOn-siteContractAlcon

Salary not posted. The employer did not include pay in this listing. Ask for the range in your first conversation; it is a fair question.

Posted Today · listed on Workable

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Open
1 day
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Open roles at this company
16
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Salary
Not posted
No range in the posting. Ask early. It is a fair question and it saves everyone time.

Days open comes from the posting date. Fill time and reposting rate come from this company's recent public postings.

About the role

Lead the remediation of a calibration program at a regulated manufacturing facility in Houston, Texas. You will assess the current state, close compliance gaps and build a metrology program that holds up to internal, customer and regulatory audits.

What you'll do

  • Run gap assessments of metrology and calibration programs and build remediation plans.
  • Address audit observations, CAPAs and regulatory findings related to calibration.
  • Evaluate out-of-tolerance conditions and their product and validation impact.
  • Apply MSA, measurement uncertainty, guard banding and fitness-for-use decision rules.
  • Author calibration procedures, deviations, CAPAs and risk assessments; train personnel.

Requirements

  • Bachelor's degree in Engineering, Quality, Metrology or related.
  • 5+ years in metrology, calibration or equipment quality engineering in a regulated industry.
  • Experience leading calibration program remediation.
  • ISO 13485, 21 CFR 820/QMSR, ISO 17025 principles, Gage R&R/MSA.
  • Minitab or equivalent statistical tools.

Benefits

  • Contract: 12 months, with possible extension
  • Shift: Administrative, on-site
  • Start: Immediate

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