In this role, the selected candidate will closely monitors quality, completeness and timeliness of complaint investigations and files; reviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed.
The Quality Specialist is responsible for the administrative and scientific activities for clinical projects including clinical screening, data compilation, and documentation of all eligible patient cases.
Coordinates or develops standard operating procedures for field staff and maintenance personnel; prepares and/or maintains computer programs for the compiling and statistical analysis of quality assurance data.
In this role, you will perform quality review and analysis of training programs delivered at various locations throughout a district. Administer, organize, and conduct training and educational programs in connection with management and promotional development, On-the-job training, and employee orientation.
Evaluate all including complex audit findings to determine severity, i.e., critical, major or minor, and provide advice and guidance in developing corrective and preventative course of action to resolve audit findings.
This position is responsible for administering aspects of the Quality Management System related to quality system compliance and continuous improvement. The ideal candidate will have a Quality Specialist/Engineering background in a medical device/in-vitro diagnostic, or molecular reagent company.
Analyze, define, implement, and execute quality and test related activities according quality and test strategy. Create a detailed test design including test system landscape definition and product standards, and prepare tests (customizing & master data), author and execute manual and/or automated tests.