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Quality Assurance Engineer
2 months ago
Title: Quality Assurance Engineer (Medical Device)
Location: Scarborough, Maine
Duration: 06+ Month
Summary:
- 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.
