My name is Chrys and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Engineer, Quality for a prominent client of ours. This position is located in Westford, MA Details for the position are as follows:
- 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.
If you are interested in hearing more about the position please respond to this posting with your resume attached.