Calibration & Metrology Quality Engineer (On-Site)

BioPharma Consulting JAD Group; Georgia; Sur place; USD 96 000 - 138 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Gap assessment

Remediation planning

CAPA management

Regulatory audit support

Metrology knowledge

Calibration procedures

Training personnel

Formation

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

5+ years in metrology/calibration in a regulated industry

Outils

Minitab

Statistical tools

Description du poste

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.