Quality Control Engineer II

Tech in Motion; Houston (TX); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

Motion Recruitment is seeking a Senior Quality Engineer - Metrology in Houston to lead calibration program remediation and risk-based QA activities in a regulated medical device environment.

You will drive OOT/OOC investigations, CAPAs, and measurement-system evaluations, collaborating with Engineering, Manufacturing, Validation, Lab Ops, and Quality teams. A strong background in metrology and ISO/Regulatory standards is required.

Qualifikationen

• 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.
• 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.

Aufgaben

• Lead calibration program assessments and remediation initiatives (metrology focus).
• 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.

Kenntnisse

Quality engineering

Metrology

Calibration

Gage R&R

MSA

ISO 13485

21 CFR 820

Risk assessment

CAPA

Statistical analysis

Tools

Minitab

Teamcenter

Jobbeschreibung

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

Contract Duration: 12 Months

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
• 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

What You Will Be Doing

Tech Breakdown

• Metrology / Calibration Program Remediation - 70%
• Risk Assessment, Compliance, and Quality Systems Activities - 30%

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