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Sr. Quality Engineer

Exalta Group -
Bethlehem, PA

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Job Details

Full-time

Qualifications

Inspection gauge
Statistics
Measurement-based inspection
Dimensional measurements
Parts drawings
Hand tools

Full Job Description

Quality Engineer – Quality Control (QC QE)

Position Summary

The Quality Engineer – Quality Control (QC QE) provides technical Quality Engineering support to ensure inspection and measurement activities are capable, appropriate, and consistently applied across manufacturing sites.

This role will focus heavily on measurement system capability, inspection method selection, Gauge R&R/MSA, correlation of inspection methods across sites, and standardization of Quality Control practices. The QC QE will work closely with Quality, Engineering, Metrology, and Operations to ensure the right measurement method is being used for each product characteristic and that inspection systems are capable of reliably determining product conformity.

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.

Decision Authority

The QC QE may recommend changes to inspection methods, measurement equipment, sampling strategies, and inspection frequency based on technical and statistical analysis.

Final approval for changes to established inspection requirements or inspection reductions remains with Quality Assurance.

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.

Key Measures of Success

Capable and appropriately qualified measurement systems.
Strong MSA and Gauge R&R performance.
Consistent inspection methodologies across manufacturing sites.
Reduction in measurement discrepancies between sites.
Improved selection of inspection equipment and methods.
Standardized QC practices and inspection instructions.
Reduced inspection inefficiency without compromising product quality.
Reliable inspection data that supports sound Quality decisions.

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Quality Engineer – Quality Control (QC QE)

Position Summary

Key Responsibilities

Decision Authority

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