Engineer Quality

The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities. Provide inprocess QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers contractors and consultants that supply components subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection calibration MRB etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish monitor and evaluate quality system metrics.