Engineer, Quality

Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, a global medical devices and health care company that is engaged in the discovery, development, and manufacturer of medical equipment and healthcare products.

• 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.

• 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.

• Supplier Quality Engineer with 1-3 years' experience in Medical Device Industry preferably has worked with supplier. Responsibilities will include Supplier CAPA (Non-conformance materials investigations), Completing material qualifications including process validation/verifications for Hardware and Disposable materials and completing Supplier Change Notifications.