Sr. Quality Engineer

Sr. Quality Engineer

Exciting Sr. Quality Engineer opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care

Contract: 1 year with extension or conversion potential

Location: Houston - Relocate is not available, seeking a local candidate

Benefits: Medical, Dental, Holiday, PTO 401K matching

Seeking an experienced Quality Engineer with 5+ years of metrology and calibration experience, preferably in the medical device industry. The ideal candidate will assess calibration programs, identify compliance gaps, lead remediation efforts, and ensure audit and regulatory readiness.

• Lead calibration program remediation, addressing audit findings, CAPAs, and overdue calibrations.
• Perform gap assessments, risk evaluations, and out-of-tolerance (OOT) product impact assessments.
• Apply metrology principles, including measurement uncertainty, traceability, tolerance analysis, guardbanding, and Gage R&R.
• Support calibration of manufacturing and inspection equipment, including CMMs, vision systems, ultrasonic welders, presses, and packaging equipment.
• Develop and revise calibration procedures, CAPAs, deviations, and risk assessments.
• Ensure compliance with ISO 13485, 21 CFR Part 820/QMSR, and ISO 17025 principles.
• Analyze calibration trends using Minitab or similar statistical tools.
• Collaborate with Engineering, Manufacturing, Validation, and Quality teams to drive improvements and support audits.

Required Qualifications

• 5+ years of Quality Engineering or Metrology experience.
• 2+ years supporting calibration program remediation in a regulated manufacturing environment.
• Strong knowledge of dimensional metrology, calibration systems, MSA, and measurement uncertainty.
• Experience with OOT investigations, CAPAs, and product impact assessments.
• Strong analytical, problem-solving, and cross-functional leadership skills.

Preferred Qualifications

• Medical device manufacturing experience.
• Knowledge of ISO 9001, ISO 13485, ISO 17025, ISO 10012, and ANSI/NCSL Z540.
• Familiarity with ProCal V5, Siemens Teamcenter, and cleanroom environments

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH