FierceBiotech and FiercePharma Jobs
Quality Assurance Manager - NAMSA
Jun 12
Location: Irvine, CACategories: All Categories
Website: http://www.namsa.com
Position Description
NAMSA, the world leader in medical device testing has an immediate opening for a Quality Assurance Manager. Responsibilities will include oversight of the GLP/GMP quality assurance function for a single location, including staffing, budgeting, and training. The Quality Assurance Manager serves as the management representative for ISO 13485 and Quality System Regulation (QSR) and is the primary interface for regulatory agencies for regulatory audits and submissions, and responsible for hosting client audits.
The successful candidate will have a Bachelor’s degree in a scientific discipline and a minimum of 5 years quality experience, including 2 years management experience. Must have a working knowledge of 21 CFR 211, 21 CFR 820, 21 CFR 58, and ISO 13485; knowledge of ISO 17025 is preferred.
