Validation Engineer
1 week ago
Not for C2C
Title: USA - Validation Engineer
Locations: Medina NY
Duration: 3+ Months + Extensions
Write reports summarizing results and statistics for all equipment, product, or process validation projects.
Trend and report on the Manufacturing NCRs – including process effectiveness and corrective and preventative actions and make recommendations for improvements.
Develop and communicates expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
Support the Quality Management System
Lead the development and execution of engineering studies, quality plans, validation packages
Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
Knowledge and working application of reading and understanding blue prints and technical drawings.
Desired CQE, CSSBB, CQA or initiative to complete certifications.
Prefer experience with TQM methods (e.g. "six sigma").
Internal Quality System auditing experience (ISO 13485 and FDA 21CFR820).
REQUIRED
Bachelor’s degree in Engineering
5-8 years of related experience
Six Sigma Certification (. Belt or Black Belt) is desirable
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