Senior Quality Engineer - Metrology and Calibration

BioPharma Consulting JAD Group • Houston, TX

1d • Onsite

About The Position

Lead remediation of a calibration program at a regulated manufacturing facility in Houston, Texas. Assess the current state, close compliance gaps, and build a metrology program that can withstand internal, customer, and regulatory audits. This is a 12-month contract with a possible extension. The position is administrative and on-site, with an immediate start.

Requirements

• Bachelor’s degree in Engineering, Quality, Metrology, or a related field.
• At least 5 years of experience in metrology, calibration, or equipment quality engineering in a regulated industry.
• Experience leading calibration program remediation.
• Knowledge of ISO 13485, 21 CFR 820/QMSR, and ISO 17025 principles.
• Experience with Gage R&R/MSA.
• Experience with Minitab or equivalent statistical tools.

Responsibilities

• Run gap assessments of metrology and calibration programs and develop remediation plans.
• Address audit observations, CAPAs, and regulatory findings related to calibration.
• Evaluate out-of-tolerance conditions and their impact on products and validation.
• Apply MSA, measurement uncertainty, guard banding, and fitness-for-use decision rules.
• Author calibration procedures, deviations, CAPAs, and risk assessments.
• Train personnel.

What This Job Offers

• Career Level: Senior