The Sr. Quality Engineer supports Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform
Job Summary
The Sr. Quality Engineer supports Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform.
The role requires leading change management activities, risk assessments, and design transfer projects while ensuring compliance with global regulations.
Candidates will mentor junior staff, manage supplier qualifications, and drive quality improvement projects to support global expansion efforts.
Matching Summary
The Sr. Quality Engineer supports Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform.
Skills & Requirements
Must-have
Bachelor's degree in Engineering
5-8 years Quality Engineering experience
ISO14971 risk management knowledge
21CFR 820 GMP compliance expertise
Design History File maintenance
PFMEA and Control Plan development
Nice-to-have
ASQ Certified Quality Engineer certification
Six Sigma Black Belt certification
Pharmaceutical or combination product experience
MiniTab statistical software proficiency
SAP ERP system experience
Strong verbal communication skills
Key Requirements
Bachelor's degree in Engineering from accredited university
5-8 years of Quality Engineering experience
Experience with GLP, GMP, and GDP environments
ASQ CQE or Six Sigma Black Belt preferred
US work authorization required for El Paso location