In this role, you will be responsible for the day to day execution of core quality processes under the supervision of Director, Quality Assurance with mentoring from more senior QA Specialists ( Skill levels II and III )
In this role, you will be responsible for investigating complaints for potential reporting under the FDA Medical Device Reporting regulations, preparing draft complaint summaries and MDR reports for presentation to the Reportable Events Committee for review and maintaining documentation in accordance with department policies, procedures and work instructions.
The QA Specislist willdevelop, maintain software test scripts; install and maintain test environments; install and QA test software patches and updates for the stability of enterprise software (WMS and ERP) applications.
In this role, the selected candidate will collect and review quality metrics to ensure operational standardization and regulatory compliance. Analyzes data and prepares reports. Reviews and evaluates compliance gaps and implements process improvements. Conducts audits. Acts as a quality and compliance educator and consultant to operational staff. Performs other related duties as assigned.
In this role, you will perform training of analysts on analytical methods and operating procedures.Work in accordance with current procedures and demonstrate proper laboratory safety and housekeeping practices.
A successful Quality Document Specialist must be able to function in a data-driven outcomes-based patient-centric manner and identify opportunities to expand Explorys solutions in the clinical end-user environment.
In this role, you will train network of SQM administrators across GRP, automate responses to SQM data including holds, alerts and line stoppage, ensure surface monitoring systems are being used optimally.
In this role, you will provide the leadership necessary to establish and maintain quality levels of new products through preventive controls (PRPs/HACCP), raw material, process and quality systems management in a highly dynamic environment.