The candidate selected for this position is responsible for maintaining various databases that process and store quality data and also procurement records for the TEMR Department. They develop and present management reports by writing applications to take data from SQL Server and Microsoft Access databases in appropriate reporting formats.
Provide quality engineering support for OPM sponsored clinical trial monitoring, including; a. Select, audit, approve new clinical trial sites b. Provide, or assist with, the monitoring plan c. Provide or assist in clinical trial site readiness audits and training for regulatory health agency inspection.
Monitor and determine actions for first pass yield reports, scrap reports, and process audit reports.Analyze customer complaints and field failures.Coordinate corrective action, follow-up and reporting.
In this role, the selected candidate will be responsible for working closely with Software Developers and Quality Assurance Engineers to automate test cases for products and features based on business priorities and technical specifications.
This position will also be part of implementing software development tools to improve the overall quality of software, including peer reviews, software hazard analysis, requirements traceability, software code analysis/code coverage, defect tracking, software metrics, configuration management, software supplier quality, and software tool validations.
In this role, you will be responsible for develop and maintain a quality management system to be compliant with ISO 13485 for an organization that designs, manufactures and distributes medical devices.