QSCS was hired to conduct an in depth QSIT audit for a manufacturer of mechanical medical devices. During the audit, the QSCS consultant observed a welding operation that was experiencing less that acceptable yields. Over the next month, the QSCS consultant worked with the site and uncovered a strong relationship
QSCS was hired for a short engagement to link the clients Risk Management activities to other sub-systems within their Quality System. QSCS consultant successfully completed original task however while there, the consultant identified opportunities to improve statistical sampling in their validation procedures in addition to opportunities for reductions at outgoing
QSCS was hired to assist in remediating post market surveillance issues for a pharmaceutical manufacturer. Approximately 1,000 historical records were reviewed, updated, and properly documented. QSCS worked alongside the company providing recommendations and support with any and all correspondence with the FDA. While on site, one of the QSCS consultants
QSCS was hired to focus on two directives. The first was to provide full remediation and audit support in response to an FDA Warning letter. A thorough gap assessment was performed on each Quality Subsystem followed by the development and implementation of a remediation strategy. The gaps in each subsystem
QSCS was hired for a large, long term project to help support the development and implementation of a new, comprehensive Quality System in addition to the management of validations required for the installation of three large manufacturing lines. Each of these efforts were done successfully and on time. QSCS was
QSCS was hired to identify opportunities and implement solutions to increase the efficiency of the Quality Assurance department for a manufacturing plant in New York that produced electro-mechanical medical devices. While working with the QA department, the QSCS consultant also teamed with QA and Operations on the following activities: QSCS
