What are the responsibilities and job description for the Senior Quality Engineer - Metrology and Calibration position at BioPharma Consulting JAD Group?
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