Senior Metrology Quality Engineer - Hybrid (12-Month)

Motion Recruitment

Houston (TX)

Hybrid

USD 110,000 - 140,000

Full time

42 hours ago
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Job summary

Motion Recruitment is seeking a Senior Quality Engineer – Metrology for a medical device manufacturing context in Houston. You will lead calibration program assessments, remediation, and CAPA activities to strengthen metrology systems.

This hybrid role spans ISO 13485, 21 CFR Part 820, and ISO 17025 with hands-on data analysis using Minitab and involvement across Engineering, Manufacturing, Validation, and Quality teams.

Qualifications

  • 5+ years of Quality Engineering experience supporting metrology and calibration systems.
  • 2+ years leading or supporting calibration/metrology remediation in regulated manufacturing (Pharma, Medical Devices, Aerospace).
  • Strong knowledge of ISO 13485, 21 CFR Part 820/QMSR, ISO 17025, Gage R&R, and MSA methodologies.
  • Expertise in dimensional metrology, calibration principles, measurement uncertainty, tolerance analysis, traceability, and guard banding.
  • Experience conducting OOT/OOC investigations, impact assessments, CAPAs, risk assessments, and deviation management.
  • Ability to analyze calibration data and equipment performance using risk-based decision-making methodologies.
  • Experience supporting internal, customer, and regulatory audits.
  • Proficiency with Minitab or similar statistical analysis tools.

Responsibilities

  • Lead calibration program assessments and remediation initiatives.
  • Perform gap analyses and develop sustainable remediation plans.
  • Conduct OOT/OOC investigations and product impact assessments.
  • Drive CAPA activities and quality system improvements.
  • Author and revise calibration procedures, deviations, risk assessments, and impact assessments.
  • Evaluate measurement systems, calibration intervals, traceability, and fitness-for-use decisions.
  • Partner with Engineering, Manufacturing, Validation, Laboratory Operations, and Quality teams.
  • Support internal, customer, and regulatory audits.
  • Train stakeholders and implement long-term metrology process improvements.

Skills

Quality engineering
CAPA leadership
Risk assessment
Gage R&R
MSA methodologies
Measurement uncertainty
Traceability
OOT/OOC investigations
Minitab

Tools

Minitab
CMMs
Vision systems

Job description

Motion Recruitment is seeking a Senior Quality Engineer – Metrology for a medical device manufacturing context in Houston. You will lead calibration program assessments, remediation, and CAPA activities to strengthen metrology systems.

This hybrid role spans ISO 13485, 21 CFR Part 820, and ISO 17025 with hands-on data analysis using Minitab and involvement across Engineering, Manufacturing, Validation, and Quality teams.

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