Lead Metrology & Calibration Quality Engineer

BioPharma Consulting JAD Group

Houston (TX)

On-site

USD 85,000 - 125,000

Full time

2 days ago
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Benefits offered by this job

12-month contract
On-site

Job summary

BioPharma Consulting JAD Group seeks a senior metrology/calibration professional to lead remediation efforts at a regulated Houston facility. You will assess the current state, close compliance gaps and build a metrology program that withstands internal, customer and regulatory audits.

Key responsibilities include running gap assessments, addressing audit observations and CAPAs, evaluating out-of-tolerance impacts, applying MSA and Gage R&R concepts, and authoring procedures and risk assessments

Qualifications

  • Bachelor's degree in Engineering, Quality, Metrology or related field.
  • 5+ years in metrology, calibration or equipment quality in regulated environments.
  • Experience leading calibration program remediation; strong problem-solving.

Responsibilities

  • 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.

Skills

Metrology
Calibration
Audit readiness
Regulatory compliance
CAPA management

Education

Bachelor's degree in Engineering/Quality/Metrology

Tools

Minitab

Job description

BioPharma Consulting JAD Group seeks a senior metrology/calibration professional to lead remediation efforts at a regulated Houston facility. You will assess the current state, close compliance gaps and build a metrology program that withstands internal, customer and regulatory audits.

Key responsibilities include running gap assessments, addressing audit observations and CAPAs, evaluating out-of-tolerance impacts, applying MSA and Gage R&R concepts, and authoring procedures and risk assessments

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