Principal Quality System Analyst
* Developed and instituted a lifecycle development process which included development phases that met compliance requirements and defined required work activities and output documentation for consistency in development processes.* Established process improvements that included developed standards for requirements, technical documentation, testing plans and reports that defined consistency in documentation, met regulatory requirements, and resulted in improved quality of documentation and delivered products.* Developed and delivered a 40 hour new employee training course for departmental personnel that introduced employees to corporate and departmental procedures, requirements and practices.* Coordinated departmental required audits that ensured compliance and that were conducted by corporate and external regulatory personnel.* Worked with compliance to re-write departmental procedures to meet ISO 13485 requirements.
