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Senior Quality Engineer - Metrology and Calibration

BioPharma Consulting JAD Group · Houston, Stati Uniti d'America · On-site

  • Ufficio in Houston
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Description

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