Motion Recruitment

Quality Control Engineer II

Houston, TX, United States

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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