Westford, MA
Engineer, Quality
Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, a global pharmaceutical company that is engaged in the discovery, development and manufacturer of healthcare products.
Job Title: Quality Engineer
Location: Westford, MA
Duration: 24+ Months (possibly extension)
Job Descriptions:
- 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.
APPLY TODAY!
Recommended Skills
- Calibration
- Corrective And Preventive Action (Capa)
- Failure Analysis
- International Standards
- Metrics
- Quality Management
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