Senior Quality Engineer - Metrology and Calibration

BioPharma Consulting JAD Group; Georgia; On-site; USD 96,000 - 138,000; Full time

Job summary

BioPharma Consulting JAD Group leads 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 withstands internal, customer, and regulatory audits.

Key duties include conducting gap assessments, addressing audit observations and CAPAs, evaluating out-of-tolerance conditions, and applying MSA and measurement-uncertainty principles.

Qualifications

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

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

Gap assessment

Remediation planning

CAPA management

Regulatory audit support

Metrology knowledge

Calibration procedures

Training personnel

Education

Bachelor's degree in Engineering, Quality, Metrology or related

5+ years in metrology/calibration in a regulated industry

Tools

Minitab

Statistical tools

Job 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.

• 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.

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