Senior Quality Engineer - Automation & Data-Driven QMS

DuPont™ Spectrum™; Sandy (UT); On-site; USD 118,000 - 128,000; Full time

Job summary

Apollo Medical Extrusion Technologies, Inc. seeks a Sr. Quality Engineer to ensure regulatory compliance (ISO 13485, FDA QSR) and drive robust quality programs in product and process development at our Sandy, Utah site.

You'll develop validation protocols (TMV, IQ/OQ/PQ), maintain risk management files, lead CAPA investigations, and support supplier quality and internal audits while advancing Quality 4.0, eQMS, and data analytics with PowerBI and Minitab.

Qualifications

• Bachelor’s degree in Mechanical or Industrial Engineering required.
• Master’s degree in the same field accepted with 3 years experience.
• Five years of Quality Engineer or related experience; Lean Six Sigma projects preferred.

Responsibilities

• Ensure regulatory compliance (ISO 13485, FDA QSR) for product/process development.
• Develop/execute validation protocols (TMV, IQ/OQ/PQ) and risk management files.
• Lead CAPA investigations, root cause analysis, and corrective actions.
• Support customer interactions, supplier quality, and internal audits.
• Drive automation initiatives, eQMS, and Quality 4.0; analyze data with PowerBI/Minitab.

Skills

Quality engineering

Root cause analysis

CAPA

Lean Six Sigma

Data analytics

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Master’s degree in Mechanical or Industrial Engineering

Tools

Automated measurement systems

Vision systems

CMMs

PowerBI

Excel VBA

Pivot Tables

eQMS

Minitab

DOE

Gage R&R

Job description

Apollo Medical Extrusion Technologies, Inc. seeks a Sr. Quality Engineer to ensure regulatory compliance (ISO 13485, FDA QSR) and drive robust quality programs in product and process development at our Sandy, Utah site.

You'll develop validation protocols (TMV, IQ/OQ/PQ), maintain risk management files, lead CAPA investigations, and support supplier quality and internal audits while advancing Quality 4.0, eQMS, and data analytics with PowerBI and Minitab.