Supplier Quality EngineerThis is a onsite position. 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 include:Developing incoming inspection processes and documenting incoming inspection activities. Providing in-process QA support to include inspection and document review. Completing final acceptance activities. Managing the sterilization process, including validations and product sterile loads.
Tracking nonconforming material and leading Material Review Board (MRB) efforts. Interface and taking lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Leading complaint investigations on returned product. Managing corrective action and quality improvement activities.
Managing aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assisting in the performance of quality system internal auditing. Supporting quarterly management review meetings. Establishing, monitoring and evaluating quality system metrics.This is for Supplier Quality Engineer with minimum 2 years of experience in medical device space.