Description :
The Opportunity: This is an opportuinty to join a fast paced medical device company that designs, develops, manufactures, and markets innovative products that improve the quality of people's lives. In this role, you will provide Quailty Engineering support to both the manufacture and development of medical device products. Education and Experience Requirements: BS or MS in an engineering discipline and a minimum of 3 years of medical device quality engineering experience. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Skilled in test plan development and root cause failure analysis; experience with CAPA management and processes. Skilled in statistical methods, sampling plans, gauge R&R, and design of experiments. ASQ CQE certification is desired.