QA MANAGER en Mexicali

BREG MEXICO S DE RL DE CV
BREG Inc., a leading manufacturer of over 200 medical products, is currently searching for following position our Mexicali plant. BREG is an Orthofix company, headquartered in San Diego, Ca. Our innovative products are widely recognized in the U.S. and International marketplaces and we are considered one of the fastest growing health care manufacturers.
 QA ManagerResponsibilities
QA Manager has responsibility for oversight and direction of quality assurance activities in a manufacturing setting.Manages the Quality Assurance program that includes: Quality system, document control, internal audits, calibration, receiving/first article inspection, floor audits, and product inspection.
Develops procedures and methods in support of the Quality Assurance program. Serves as Executive w/Management Review for the Quality System and chairs ManageRequirementsIndividual must have 4 to 7 years experience in Quality Assurance in a medical device field with increasing levels of responsibility in: quality control, quality assurance, and quality engineering. Should have formal training in the concepts of FDA GMP and ISO 13485/ISO9000 applications. Process engineering experience would be a plus. Professional certification as CQE, CQM or CQA is highly desirable. Certification or formal training as an Auditor &/or Quality Engineer is highly desirable.