Under the direction of the QC Manager, the QC Technician is responsible for following defined QC procedures and providing inspection and testing on the shift assigned. Primary responsibility is to ensure that only acceptable components and assemblies are approved and accepted in our ISO/GMP Manufacturing environment.
- Be able to follow quality procedures, QWI’s and QCIP’s. Completes required quality record documentation completely and correctly on a daily basis. Assures effective communication during the course of workday and at shift change. Demonstrates knowledge of daily work responsibilities.
- Be able to set up and use all QC Department measuring and testing equipment, as well as identify equipment that is not in proper working condition.
- Be able to understand and use QA specifications, STP’s, Engineering drawings and other engineering specifications.
- Support and perform QC testing not routinely performed by the Manufacturing inspection group, where specialized training is required.
- Be able to perform all SAP notification tasks as part of the NCR system.
- Maintain records in accordance with the device history file system.
- Be able to communicate inspection findings with appropriate personnel in the Quality, Manufacturing and Engineering departments. Participate in corrective action activities.
- Be able to support and perform Engineering work orders with higher levels of complexity than the Manufacturing inspection group.
- Review completed lot files for accuracy, documentation errors and completeness including electronic records prior to making a usage decision. Be able to perform usage decisions on standard product files and assure maintenance of the batch record storage system.
- Assure product release of variances, reworks, requests and other assignments from QC Manager.
- Support QC auditor in assuring quality requirements and expectations are satisfied on the shift assigned.
- Minimum of a high school diploma or GED
- Proficient in SAP QM system
- Certification by ASQ is a plus
- Previous experience as a Manufacturing QC Inspector required