Quality Engineer
8-month Contract
Onsite in Scarborough, ME
Must be able to work on a W2
Job Description
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.
Requirements
- Develop incoming inspection processes and document incoming inspection activities
- Provide in-process QA support, including 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 a 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 the 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
Qualifications
- 3+ years of experience
- Experience working in accordance with FDA Quality System Regulation, ISO13485, and other international standards
- Experience supporting device complaint investigation and failure analysis
