QUALITY ENGINEER

My client, a manufacturer of medical equipment, located in the Greater Cincinnati area is seeking an experienced Quality Engineer. This individual will be responsible for Quality support of the various departments of the facility.

Responsibilities:

Assure Quality Systems comply with all applicable sections of 21 CFR, ISO standards and internal quality system procedures
Failure analysis of product systems for identification of corrective an preventative action
Conduct internal and supplier Quality System audits to assure compliance with domestic regulations and international requirements
Apply best quality assurance methods and practices in support of Quality objectives
Perform Process Validation (IQ, OQ, & PQ) for new product transition from R&D to manufacturing and production
Performs trending of Quality data to proactively identify opportunities for System improvements
REQUIREMENTS
BS Engineering
2+ years of quality system development experienced required
ISO 9001 or ISO13485 Quality Standards
CAPA experience
FDA, GMP and Medical Device Directive required
ASQ Certification preferred
Six Sigma Certification preferred

If interested in this position send your resume in Word format to [Click here for email] Attn: Herschel Miller

Key Words: Quality Engineer, Continuous Improvement, Medical Device, Medical Equipment, ISO13485, ISO 9001, FDA, GMP, CAPA, Six Sigma, ASQ, IQ, OQ, PQ, Quality System, 21CFR, Cincinnati, Ohio