Sr. Quality Engineer
About The Position
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.
Requirements
- 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.
Nice To Haves
- Medical device or other regulated manufacturing experience preferred.
- Knowledge of ISO 13485 and applicable FDA requirements preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
