*********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.
