Sr. Quality Engineer

Key Responsibilities

• Lead and support Measurement System Analysis (MSA), Gauge R&R, correlation studies, and inspection/test method qualification.
• Evaluate CMMs, vision systems, custom gauges, hand tools, fixtures, and other measurement methods to ensure they are appropriate and capable for the characteristics being inspected.
• Determine the most appropriate inspection methodology based on tolerance, feature complexity, measurement capability, risk, and manufacturing process.
• Identify situations where existing inspection methods are inadequate, overly complex, inefficient, or introduce unnecessary measurement variation.
• Drive alignment of inspection methods across sites to ensure the same characteristics are measured using technically equivalent and reproducible methods.
• Investigate discrepancies in measurement results between sites, equipment, programs, inspectors, suppliers, and customers.
• Partner with Engineering and Metrology to develop and qualify new inspection methods where needed.
• Review inspection plans and requirements to ensure inspection methods, equipment, sampling, and acceptance criteria are technically appropriate.
• Analyze inspection and measurement data to identify recurring issues, measurement variation, process drift, and opportunities for improvement.
• Support development of standardized inspection instructions and measurement practices across the organization.
• Provide technical coaching to inspectors on measurement techniques, drawing interpretation, GD&T, and appropriate use of inspection equipment.
• Support new product introductions and product transfers by ensuring inspection methods, equipment, programs, MSA, and documentation are established prior to implementation.
• Identify opportunities to optimize inspection based on demonstrated measurement capability, process performance, historical data, and risk.
• Prepare technical and statistical justification for proposed inspection strategy changes for Quality Assurance review and approval.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline; equivalent technical experience may be considered.
• 5+ years of Quality Engineering, Metrology, Quality Control, or precision-manufacturing experience.
• Strong experience with MSA and Gauge R&R.
• Experience with CMM, vision systems, hand measurement tools, and custom gauges.
• Strong understanding of engineering drawings, tolerances, and GD&T.
• Experience with statistical analysis and data-driven problem solving.
• Experience developing or qualifying inspection and measurement methods.
• Medical device or other regulated manufacturing experience preferred.
• Knowledge of ISO 13485 and applicable FDA requirements preferred.