Equipment Validation Engineer

*********DIRECT HIRE POSITION********

*********ON-SITE, NOT REMOTE, NOT HYBRID******

*********NO VISA TRANSFERS/NO VISA SPONSORSHIP******

***********NO RELOCATION ASSISTANCE***********

Quality Validation Engineer - Medical Device Industry

We are a global leader in designing and manufacturing drug delivery devices for the pharmaceutical, biotechnology, and generics industries. We are seeking a Quality Validation Engineer with mandatory experience in equipment validation within the medical device manufacturing sector.

Key Responsibilities:

• Manage and coordinate validation projects to ensure compliance with quality standards-equipment validation experience is essential .
• Lead investigations into customer complaints and implement corrective actions.
• Oversee supplier performance and ensure alignment with FDA, QSR, ISO, and customer requirements.
• Develop and analyze statistical data to drive quality improvements.

Qualifications:

• Equipment validation experience is a must -candidates without it will not be considered.
• Bachelor's degree in Engineering, Science, or related field.
• 3+ years of experience in a Quality role, preferably in the medical device industry (ISO 13485).
• Strong communication skills and ability to work independently.
• Six Sigma training or certification preferred.

Work Environment:

• Clean manufacturing environment with required PPE and cleanroom apparel.
• Ability to lift up to 30 lbs and travel up to 15%, to vendors.