Senior Quality Engineer – Automation & Data-Driven QA

Apollo Medical Extrusion; Sandy (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

Apollo Medical Extrusion Technologies, Inc. is seeking a Senior Quality Engineer to own quality across product and process development.

The role requires ensuring compliance with ISO 13485 and FDA QSR, developing validation protocols (TMV/IQ/OQ/PQ), and maintaining risk management files. The successful candidate will lead data-driven quality improvements using SPC, COPQ tracking, and advanced analytics (PowerBI, Excel VBA).

Qualifications

• Bachelor’s degree in Mechanical or Industrial Engineering or related field is required.
• Five years of experience as a Quality Engineer or related role is required.
• Experience with Lean-Six Sigma projects and COSQ metrics is required.

Responsibilities

• Oversee quality aspects of product and process development per ISO 13485 and FDA QSR.
• Develop and execute validation protocols (TMV, IQ, OQ, PQ).
• Maintain risk management files including dFMEAs and pFMEAs and control plans.

Skills

Lean Six Sigma

Data Analytics

SPC

PowerBI

Excel VBA

Gage R&R

CAPA

GD&T

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Master’s degree in Mechanical or Industrial Engineering (optional)

Tools

CMMs (Vision systems)

Gage R&R tools

Job description

Apollo Medical Extrusion Technologies, Inc. is seeking a Senior Quality Engineer to own quality across product and process development.

The role requires ensuring compliance with ISO 13485 and FDA QSR, developing validation protocols (TMV/IQ/OQ/PQ), and maintaining risk management files. The successful candidate will lead data-driven quality improvements using SPC, COPQ tracking, and advanced analytics (PowerBI, Excel VBA).