Stephanie Stuart Email & Phone Number

Conroe Tx

Conroe Tx

Vice President of quality operations for class II medical device facility specializing in the manufacturing, packaging, sterilization and international distribution of single- use, disposable class II medical products used in cardiovascular and general surgery.• Oversee contract supply chain services including OEM component manufacturing, kit assembly, ethylene oxide (EtO) sterilization, climate controlled warehousing and global distribution.• Lead and manage the performance of the site’s Quality System and Quality Control processes in achieving all established customer requirements and all applicable regulatory agency requirements.• Ensure compliance with all established Corporate Quality System procedures, collaborated with customers to establish product quality requirements and develop customer compliance strategies.• Liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards.• Conduct quality system maintenance, root cause analysis, CAPA, failure mode and effect analysis (FMEA), environmental and health assessments, product failure investigations, statistical product/process trending and associated MDR project management, corrective and preventative action designation, mitigation, management, and closure for process/product related concerns.• Lead project management organizational interfacing to assure effective, efficient and compliant product process realization and transfer to production operations per device specifications, drawings, user requirements and required compliance mechanisms as delineated per national/international regulations including but not limited to FDA cGMP (21CFR11), GMP (21CFR820), ISO-13485.• Design, implement and validate process/product specifications (DQ, IQ, OQ, PQ), QC inspection processes and QA procedures.