Manager, Quality Assurance

Develops, implements, and maintains a total quality management system in compliance with latest requirements of FDA's Quality System Regulation (QSReg), MDD, CMDR, ISO 13485 and ISO 9001.  Manages all function of QA Department in Mfg. Building which includes quality engineering, receiving, in-process and final inspection.  Provides objectives for subordinates which includes managers and supervisors.  Plans strategies, projects and subordinate work golas based on broad organizaitonal ojectives.

Interfaces on a daily basis with Manufacturing, Product Development, Purchasing and other departments affected by the quality management system.  Ensures compliance with all QSReg, MDD, DMDR, ISO regulatory, and company quality requirements for products, componenets and raw material.  Acts as technical/quality reference in regard to quality issues as needed.

Bachelor's degree in a science, engineering, technical or business field.  Documented training in FDA's QSReg, MDD, DMDR, ISO 13485 and ISO 9001 required.  Excellent communication skills and experience working with manufacaturing, product development and corporate functions preferred.  Minimum 5 years directly related experience in a medical device insutray with first hand knowledge of above functions.  Minimum 5 years direct supervisor expeirence with demonstrated people and management skills.

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=503043-3-633