Minneapolis, MN 55442 | 3 Months
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 in-process 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.
Quality Engineer will primarily support Quality System software validation activities. This will include creating software validation documentation (user requirements, software requirements, validation testing protocol and report, etc.) and executing software validation. The software being developed is an excel file with moderate functionality. Strong understanding of excel required. Quality Systems / Medical Device experience preferred. Must be willing to sit at a location other than Plymouth, but within the MN metro.