Quality Engineer II

Job description

The Quality Engineer II is responsible for ensuring quality activities are performed in accordance with 21 CFR 820, ISO 13485, ISO 14971 and other relevant FDA and International regulations. Specific duties include: (1) independently maintaining compliance, monitoring the effectiveness of, and updating Meraqi’s Quality Management System (QMS) through SOP and QWI updates; (2) planning and executing sterilization validations using ethylene oxide, gamma and e-beam radiation; (3) monitoring ongoing sterilization process effectiveness for Class II and Class III devices through dose audits and cleanroom monitoring; (4) conducting and evaluating biological risks for Class III implantable devices; (5) providing quality input for reprocessing and cleaning validation of reusable medical devices; (6) providing product development oversight for Class II and III medical devices with focus on Design Control, Change Control, Risk Management, Production and Process Controls; (7) leading as a QA representative in design/phase reviews throughout the product development life cycle and providing critical feedback; (8) designing and implementing Device Master Record (DMR) features such as Manufacturing...