Quality Engineer

Title : Quality Engineer
Location : Plymouth MN

Job Description:

• Will be Supporting a production line and Generating non-conformance experience
• Investigation experience & CAPA's experience
• Managing a line with objectives and performance
• 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.

Education :

• BA in engineering or science degree
• 2-4 years of experience in a production area
• Prefer regulated industry experience