Senior Quality Engineer - Metrology

Motion Recruitment; Houston (TX); Híbrido; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality engineering

CAPA leadership

Risk assessment

Gage R&R

MSA methodologies

Measurement uncertainty

Traceability

OOT/OOC investigations

Minitab

Herramientas

Minitab

CMMs

Vision systems

Descripción del empleo

Exciting Senior Quality Engineer - Metrology opportunity with an established medical device manufacturing company.

Contract Duration: 12 Months

Hybrid in Houston, TX 77054

Daily 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

Required Skills & Experience

• 5+ years of Quality Engineering experience supporting metrology and calibration systems
• 2+ years of experience leading or supporting calibration/metrology remediation efforts in a regulated manufacturing environment (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

Desired Skills & Experience

• Metrology experience in the medical device industry
• Experience with CMMs, vision systems, automated assembly equipment, force/torque measurement, environmental monitoring, and packaging equipment
• Familiarity with cleanroom environments and standards including ISO 9001, ISO 10012, and ANSI/NCSL Z540
• Working knowledge of ProCal V5 and Siemens Teamcenter
• Strong project management and cross-functional leadership skills