The Quality Engineer serves as a key customer-facing role responsible for onboarding and supporting new customer programs at the Philadelphia Site
Job Summary
The Quality Engineer serves as a key customer-facing role responsible for onboarding and supporting new customer programs at the Philadelphia Site.
This position drives the transition of new products and processes from engineering to manufacturing while ensuring compliance with quality system procedures.
The role requires advanced analytical ability to drive effective root cause analysis and critical thinking for complex problem-solving in an FDA-regulated environment.
Matching Summary
The Quality Engineer serves as a key customer-facing role responsible for onboarding and supporting new customer programs at the Philadelphia Site.
Skills & Requirements
Must-have
FDA-regulated industry experience
Medical device or combination products
Root cause analysis and problem solving
Design for Assembly and Manufacturing
Validation protocol development
Nice-to-have
ASQ Certified Quality Engineer certification
Lean Six Sigma process improvement skills
Strong technical writing abilities
Supplier quality management experience
Sterilization process knowledge
Key Requirements
College or Trade Degree in engineering or related science
Minimum three years of experience in FDA-regulated industry