The Quality Specialist provides support and helps administer the Quality System. The Quality Specialist assists with administration and maintenance of the non-conformance reporting program and Cal/PM program. The Quality Specialist also performs Device History Record review on manufactured product. The Quality Specialist is responsible for administration and completion of activities related to the quality management system and QMS improvement projects as assigned. This position also assists with activities related to performing sweeps of manufacturing. This position requires strong computer skills, good attention to detail and experience with quality system functions. Project management skills are essential to success.
Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Defense Quality System;
- Assist with administration and maintain of the Non-conformance reporting (NCR) program;
- Assist with administration and maintain of the Calibration and Maintenance program;
- Perform Device History Record review of manufactured product;
- Provide guidance and training to other departments in relation to Quality System programs;
- Provide back-up support for QA functions;
- Maintain Quality System data and prepare reports;
- Special projects as requested
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