Calibration & Metrology Lead — Quality Engineer (Regulated)

Biopharma-Consulting-Jad-Group

Houston (TX)

On-site

USD 120,000 - 150,000

Full time

3 days ago

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Job summary

Biopharma-Consulting-Jad-Group seeks an experienced metrology/calibration engineer to lead remediation of a calibration program at a regulated Houston facility. You will assess current state, close compliance gaps and build a metrology program that withstands internal, customer, and regulatory audits.

You will run gap assessments, address audit observations, CAPAs, and regulatory findings; evaluate out-of-tolerance conditions, and apply MSA, measurement uncertainty, guard banding, and

Qualifications

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.

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

Quality engineering

Regulatory compliance

Statistical tools

Education

Bachelor's degree in Engineering, Quality, Metrology

Tools

Minitab

Job description

You will run gap assessments, address audit observations, CAPAs, and regulatory findings; evaluate out-of-tolerance conditions, and apply MSA, measurement uncertainty, guard banding, and

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